66. IgA腎症 IgA nephropathy Clinical trials / Disease details
臨床試験数 : 255 / 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05083364 (ClinicalTrials.gov) | February 2, 2022 | 8/10/2021 | Study of ARO-C3 in Adult Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria and Complement-Mediated Renal Disease | A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and/or Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria and Adult Patients With Complement-Mediated Renal Disease | Paroxysmal Nocturnal Hemoglobinuria;C3 Glomerulopathy;IgA Nephropathy | Drug: ARO-C3;Drug: Placebo | Arrowhead Pharmaceuticals | NULL | Recruiting | 18 Years | 70 Years | All | 62 | Phase 1 | New Zealand |
| 2 | EUCTR2020-003084-26-CZ (EUCTR) | 24/11/2021 | 13/07/2021 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study | Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | Chinook Therapeutics U.S., Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | United States;Portugal;Czechia;Taiwan;Hong Kong;Spain;Ireland;Colombia;United Kingdom;Italy;India;France;Czech Republic;Canada;Argentina;Poland;Brazil;Australia;Germany;New Zealand;Japan;China;Korea, Republic of | ||
| 3 | EUCTR2020-004892-41-DE (EUCTR) | 16/11/2021 | 09/06/2021 | Atacicept in Subjects with IgA Nephropathy (ORIGIN) | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Vera Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 2 | Belarus;United States;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Malaysia;Belgium;Poland;Australia;Germany;Korea, Republic of | ||
| 4 | NCT04905212 (ClinicalTrials.gov) | November 4, 2021 | 21/5/2021 | A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy | A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Telitacicept 160mg;Drug: Telitacicept 240mg;Drug: Placebo | RemeGen Co., Ltd. | NULL | Recruiting | 18 Years | 70 Years | All | 30 | Phase 2 | United States |
| 5 | EUCTR2018-000075-33-GR (EUCTR) | 13/10/2021 | 13/07/2021 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Greece;Thailand;Spain;Italy;Australia;China;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 6 | NCT05016323 (ClinicalTrials.gov) | September 9, 2021 | 17/8/2021 | A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy. | A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy. | IgA Nephropathy | Drug: HR19042 Capsules;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 210 | Phase 2 | China |
| 7 | EUCTR2020-004892-41-GR (EUCTR) | 06/09/2021 | 19/07/2021 | Atacicept in Subjects with IgA Nephropathy (ORIGIN) | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Vera Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 2 | United States;Belarus;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Belgium;Malaysia;Poland;Australia;Germany;Korea, Republic of | ||
| 8 | NCT05065970 (ClinicalTrials.gov) | August 31, 2021 | 14/9/2021 | Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | Immunoglobulin A (IgA) Nephropathy | Drug: Felzartamab;Other: Placebo | MorphoSys AG | NULL | Recruiting | 18 Years | 80 Years | All | 48 | Phase 2 | United States;Australia;Belgium;Bulgaria;Germany;Korea, Republic of;Malaysia;Serbia;Spain;Ukraine;United Kingdom |
| 9 | EUCTR2020-005054-19-DE (EUCTR) | 16/08/2021 | 01/04/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 10 | EUCTR2020-005054-19-CZ (EUCTR) | 28/07/2021 | 09/03/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 11 | EUCTR2020-003084-26-PL (EUCTR) | 13/07/2021 | 28/01/2021 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study | Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | Chinook Therapeutics U.S., Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | United States;Portugal;Czechia;Taiwan;Hong Kong;Spain;Ireland;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Germany;New Zealand;Japan;China;Korea, Republic of | ||
| 12 | EUCTR2020-005054-19-ES (EUCTR) | 08/07/2021 | 09/07/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 23.1;Level: PT;Classification code 10084204;Term: Sickle cell nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | Serbia;United States;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Canada;Malaysia;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 13 | EUCTR2020-005054-19-BG (EUCTR) | 30/06/2021 | 18/03/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | United States;Serbia;Czechia;Philippines;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Belgium;Malaysia;Australia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of | ||
| 14 | EUCTR2020-005054-19-BE (EUCTR) | 30/06/2021 | 07/05/2021 | A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy | A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ | IgA Nephropathy (IgAN) MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Felzartamab Product Code: MOR202 INN or Proposed INN: Felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | United States;Serbia;Philippines;Czechia;Taiwan;Spain;Ukraine;United Kingdom;Czech Republic;Canada;Belgium;Malaysia;Australia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 15 | EUCTR2020-001537-13-DE (EUCTR) | 30/06/2021 | 29/01/2021 | Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN | Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: BNJ441 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 16 | EUCTR2020-003084-26-IT (EUCTR) | 08/06/2021 | 08/06/2021 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - ALIGN | Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Atrasentan Product Code: [Atrasentan] INN or Proposed INN: Atrasentan | CHINOOK THERAPEUTICS, U.S., Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | United States;Hong Kong;Taiwan;Spain;United Kingdom;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 17 | JPRN-jRCT2071210028 | 01/06/2021 | 25/05/2021 | The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function | A Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function - The ALIGN Study | IgA Nephropathy at Risk of Progressive Loss of Renal Function | Drug: Atrasentan Film-coated tablet Other Names: CHK-01 Atrasentan Hydrochloride ABT-627 Drug: Placebo Film-coated tablet | Yamada Shuji | NULL | Pending | >= 18age old | Not applicable | Both | 24 | Phase 3 | Argentina;Australia;Brazil;Canada;China;Colombia;Czech Republic;France;Germany;Hong Kong;India;Italy;New Zealand;Poland;South Korea;Spain;Taiwan;United Kingdom;United States;Japan |
| 18 | EUCTR2020-001537-13-IT (EUCTR) | 19/05/2021 | 08/06/2021 | Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN | Lupus Nephritis (LN) - Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: [ALXN1210] INN or Proposed INN: Ravulizumab | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Taiwan;Spain;Korea, Democratic People's Republic of;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden | ||
| 19 | NCT04716231 (ClinicalTrials.gov) | May 18, 2021 | 11/1/2021 | Atacicept in Subjects With IgA Nephropathy | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IGAN) | IgA Nephropathy;Berger Disease | Biological: Atacicept;Other: Placebo to match Atacicept | Vera Therapeutics, Inc. | NULL | Recruiting | 18 Years | N/A | All | 105 | Phase 2 | United States;Australia;Belgium;Czechia;Germany;Greece;India;Korea, Republic of;Malaysia;Turkey;United Kingdom |
| 20 | EUCTR2020-001049-38-CZ (EUCTR) | 13/05/2021 | 02/02/2021 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 21 | EUCTR2020-001049-38-NL (EUCTR) | 04/05/2021 | 17/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 22 | EUCTR2020-001537-13-ES (EUCTR) | 29/04/2021 | 09/02/2021 | Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN | Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: BNJ441 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 23 | EUCTR2020-001537-13-SE (EUCTR) | 23/04/2021 | 29/01/2021 | Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) - Ravulizumab in LN or IgAN | Lupus Nephritis (LN)Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: BNJ441 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 24 | ChiCTR2100045306 | 2021-04-10 | 2021-04-10 | A multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathy | A multicenter, randomized, controlled clinical trial of Hydroxychloroquine or new Tripterygium compound in the treatment of IgA nephropathy | IgA nephropathy | Hydroxychloroquine group:Hydroxychloroquine and Kunxian capsule placebo;Kunxian capsule group:Kunxian capsule and Hydroxychloroquine placebo;Placebo group:Kunxian capsule and Hydroxychloroquine placebo; | Peking University First Hospital | NULL | Recruiting | 18 | Both | Hydroxychloroquine group:65;Kunxian capsule group:65;Placebo group:65; | China | ||
| 25 | EUCTR2020-003084-26-DE (EUCTR) | 08/04/2021 | 21/12/2020 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study) - the ALIGN Study | Immunoglobulin A Nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: atrasentan INN or Proposed INN: atrasentan Other descriptive name: ATRASENTAN | Chinook Therapeutics U.S., Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | United States;Hong Kong;Taiwan;Spain;United Kingdom;Italy;India;France;Argentina;Poland;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 26 | EUCTR2020-001049-38-NO (EUCTR) | 16/03/2021 | 19/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 27 | EUCTR2020-001049-38-IT (EUCTR) | 24/02/2021 | 20/05/2021 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallelgroup, phase III study to evaluate the efficacy and safety of LNP023 inprimary IgA nephropathy patients - Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ACTHIB - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO POLVERE+1 SIRINGA PRERIEMPITA SOLVENTE 0.5 ML Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: MENVEO - POLV.E SOLUZ.PER SOLUZ. INIETT.-USO INTRAMUSCOLARE-COMP. CONIUG.LIOFILIZZ.MENA:FLAC.(VETRO) COMP. GONIUG.LIQUI.MENCWY:FLAC.(VETRO)-1 FLAC+1FLAC Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO Trade Name: BEXSERO - SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - SIRINGA PRERIEMPITA (VETRO) - 0.5ML - 1 SIRINGA PRERIEMPITA CON AGO Product Name: - Product Code: [-] INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML Product Name: - Product Code: [-] | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 28 | EUCTR2020-001049-38-SE (EUCTR) | 23/02/2021 | 02/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 29 | EUCTR2020-001049-38-BE (EUCTR) | 17/02/2021 | 17/02/2021 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 30 | NCT04578834 (ClinicalTrials.gov) | January 25, 2021 | 9/9/2020 | Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients | IgA Nephropathy | Drug: Placebo;Drug: LNP023 | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 450 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Russian Federation;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;United Kingdom;Vietnam |
| 31 | EUCTR2020-001049-38-FR (EUCTR) | 13/01/2021 | 02/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Thailand;Spain;Israel;Russian Federation;Colombia;Italy;Vietnam;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 32 | EUCTR2020-001049-38-DK (EUCTR) | 07/01/2021 | 11/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Spain;Thailand;Russian Federation;Israel;Colombia;Italy;India;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 33 | EUCTR2020-001049-38-FI (EUCTR) | 31/12/2020 | 10/12/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Thailand;Spain;Russian Federation;Israel;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden | ||
| 34 | EUCTR2020-001049-38-DE (EUCTR) | 17/12/2020 | 06/11/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Thailand;Spain;Russian Federation;Israel;Colombia;Italy;India;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Norway;Germany;Japan;Sweden | ||
| 35 | EUCTR2020-001049-38-HU (EUCTR) | 17/12/2020 | 27/10/2020 | Study of efficacy and safety of LNP023 in primary IgA nephropathy patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Thailand;Spain;Israel;Russian Federation;Colombia;Italy;Vietnam;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 36 | NCT04573478 (ClinicalTrials.gov) | December 11, 2020 | 12/9/2020 | Atrasentan in Patients With IgA Nephropathy | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function | IgA Nephropathy;Immunoglobulin A Nephropathy | Drug: Atrasentan;Drug: Placebo | Chinook Therapeutics U.S., Inc. | NULL | Recruiting | 18 Years | N/A | All | 320 | Phase 3 | United States;Australia;Brazil;Canada;France;Germany;Hong Kong;Italy;Japan;Korea, Republic of;New Zealand;Poland;Spain;Taiwan |
| 37 | ChiCTR2000038104 | 2020-09-01 | 2020-09-10 | Efficacy and safety of Artesunate for patients with IgA nephropathy: a multicenter, double-blind, randomized, placebo-controlled trial. | Efficacy and safety of Artesunate for patients with IgA nephropathy: a multicenter, double-blind, randomized, placebo-controlled trial. | IgA nephropathy | Group 1:Artesunate 100mg (50mg/Bid);Group 2:Artesunate 50mg (25mg/Bid);The control group:Placebo; | Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine | NULL | Recruiting | Both | Group 1:40;Group 2:40;The control group:40; | China | |||
| 38 | NCT04287985 (ClinicalTrials.gov) | July 20, 2020 | 10/2/2020 | Safety and Efficacy Study of VIS649 for IgA Nephropathy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A (IgA) Nephropathy | Immunoglobulin A Nephropathy;Glomerular Disease;IgAN | Drug: Dose-Placebo;Drug: Low Dose-VIS649;Drug: Medium Dose-VIS649;Drug: High Dose-VIS649 | Visterra, Inc. | NULL | Recruiting | 18 Years | N/A | All | 144 | Phase 2 | United States;Australia;Canada;Hong Kong;India;Japan;Korea, Republic of;Malaysia;Philippines;Singapore;Spain;Sri Lanka;Taiwan;Thailand;United Kingdom |
| 39 | NCT04291781 (ClinicalTrials.gov) | April 13, 2020 | 27/2/2020 | A Study of RC18 Administered Subcutaneously to Subjects With IgA(Immunoglobulin A) Nephropathy | Phase II Clinical Trial of RC18(Recombinant Human B Lymphocyte Stimulator Receptor - Antibody Fusion Protein for Injection) in the Treatment of IgA Nephropathy | IgA Nephropathy | Biological: RC18 160mg;Biological: RC18 240mg;Biological: placebo | RemeGen Co., Ltd. | NULL | Completed | 18 Years | 70 Years | All | 44 | Phase 2 | China |
| 40 | EUCTR2019-002531-29-GB (EUCTR) | 24/03/2020 | 17/12/2019 | A study to look at the effect and how safe drug VIS649 is in patients with kidney disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy | Immunoglobulin A (IgA) Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: VIS649 Product Code: VIS649 INN or Proposed INN: VIS649 Other descriptive name: VIS649 Product Name: VIS649 Product Code: VIS649 INN or Proposed INN: VIS649 Other descriptive name: VIS649 Product Name: VIS649 Product Code: VIS649 INN or Proposed INN: VIS649 Other descriptive name: VIS649 | Visterra, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 2 | United States;Philippines;Hong Kong;Taiwan;Thailand;Spain;United Kingdom;India;Czech Republic;Canada;Malaysia;Singapore;Australia;Japan;Korea, Republic of | ||
| 41 | EUCTR2018-000075-33-DE (EUCTR) | 19/12/2019 | 01/07/2019 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 42 | EUCTR2017-000891-27-IT (EUCTR) | 18/12/2019 | 30/09/2019 | Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 43 | EUCTR2018-000075-33-GB (EUCTR) | 06/11/2019 | 27/06/2019 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of | ||
| 44 | EUCTR2017-000891-27-FR (EUCTR) | 29/10/2019 | 12/08/2019 | Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 45 | EUCTR2017-000891-27-CZ (EUCTR) | 10/10/2019 | 03/07/2019 | Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 46 | EUCTR2018-000075-33-IT (EUCTR) | 26/09/2019 | 18/06/2021 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: OMS721 Product Code: [OMS721] INN or Proposed INN: OMS721 | OMEROS CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden | ||
| 47 | EUCTR2017-000891-27-HU (EUCTR) | 25/09/2019 | 30/07/2019 | Study of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Germany;Norway;Japan;Sweden;United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore | ||
| 48 | NCT03418779 (ClinicalTrials.gov) | July 4, 2019 | 11/1/2018 | Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRD | Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE) | IgA Nephropathy at High Risk of Developing ESRD | Drug: The Yi-Qi-Qing-Jie herbal compound;Drug: Immunosuppressants;Other: Optimized Supportive Care;Other: Yi-Qi-Qing-Jie herbal compound placebo | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | China Academy of Chinese Medical Sciences | Recruiting | 18 Years | 70 Years | All | 60 | Phase 2/Phase 3 | China |
| 49 | EUCTR2018-002716-27-GB (EUCTR) | 11/06/2019 | 07/01/2019 | A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: cemdisiran Product Code: ALN-CC5 INN or Proposed INN: cemdisiran Other descriptive name: CEMDISIRAN | Alnylam Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;France;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden | ||
| 50 | EUCTR2018-002716-27-SE (EUCTR) | 28/05/2019 | 06/02/2019 | A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: cemdisiran Product Code: ALN-CC5 INN or Proposed INN: cemdisiran Other descriptive name: CEMDISIRAN | Alnylam Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | France;United States;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden | ||
| 51 | EUCTR2017-004366-10-GB (EUCTR) | 24/05/2019 | 04/02/2019 | Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy | A Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy | Immunoglobulin A (IgA) nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® (belimumab) Product Name: BENLYSTA® (belimumab) Product Code: GSK1550188 INN or Proposed INN: Belimumab Other descriptive name: GSK1550188; Benlysta | University of Leicester | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 21 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 52 | NCT03841448 (ClinicalTrials.gov) | April 24, 2019 | 13/2/2019 | A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN) | A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy | IgA Nephropathy (IgAN);Berger Disease;Glomerulonephritis, IgA | Drug: Placebo;Drug: Cemdisiran | Alnylam Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 65 Years | All | 31 | Phase 2 | Canada;France;Malaysia;Philippines;Singapore;Spain;Sweden;Taiwan;United Kingdom;United States |
| 53 | NCT03945318 (ClinicalTrials.gov) | April 8, 2019 | 21/4/2019 | Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN) | A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy | IgA Nephropathy | Drug: BION-1301 Single Dose;Drug: Placebo Single Dose;Drug: BION-1301 Multiple Doses;Drug: Placebo Multiple Doses | Chinook Therapeutics, Inc. | NULL | Recruiting | 18 Years | N/A | All | 112 | Phase 1/Phase 2 | United States;United Kingdom |
| 54 | EUCTR2018-002716-27-ES (EUCTR) | 08/04/2019 | 12/04/2019 | A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy | Immunoglobulin A nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: cemdisiran Product Code: ALN-CC5 INN or Proposed INN: cemdisiran Other descriptive name: CEMDISIRAN | Alnylam Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Philippines;Taiwan;Spain;United Kingdom;France;Canada;Malaysia;Singapore;Australia;Germany;Sweden;Korea, Republic of | ||
| 55 | ChiCTR1900022100 | 2019-04-01 | 2019-03-25 | Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of deficiency-wind-stasis -toxin” | Evaluation of clinical efficacy of Modified Huangqi Chifeng Decoction in treating IgA Nephropathy proteinuia based on Chinese medicine pathogenesis of deficiency-wind-stasis -toxin” | IgA nephropathy | Placebo Group:Placebo+telmisartan;Experimental group:Flavoured huangqi chifeng granules+telmisartan; | Xiyuan Hospital, China Academy of Chinese Medical Sciences | NULL | Recruiting | Both | Placebo Group:40;Experimental group:40; | N/A | China | ||
| 56 | EUCTR2017-004902-16-IT (EUCTR) | 16/11/2018 | 20/01/2021 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primar | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: [Nefecon] INN or Proposed INN: BUDESONIDE | CALLIDITAS THERAPEUTICS AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 57 | EUCTR2018-000075-33-AT (EUCTR) | 15/11/2018 | 25/06/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of | ||
| 58 | NCT03719443 (ClinicalTrials.gov) | October 9, 2018 | 10/10/2018 | First in Human Study to Assess Safety of VIS649 in Healthy Subjects | A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy Subjects | Immunoglobulin A Nephropathy;IgAN - IgA Nephropathy;IgA Nephropathy | Biological: VIS649;Biological: Placebo | Visterra, Inc. | NULL | Completed | 18 Years | 55 Years | All | 41 | Phase 1 | United States |
| 59 | EUCTR2018-000075-33-BE (EUCTR) | 03/10/2018 | 31/05/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 60 | EUCTR2018-000075-33-PL (EUCTR) | 17/09/2018 | 10/07/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 61 | EUCTR2018-000075-33-CZ (EUCTR) | 06/09/2018 | 06/04/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of | ||
| 62 | EUCTR2018-000075-33-BG (EUCTR) | 05/09/2018 | 19/07/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 63 | NCT03643965 (ClinicalTrials.gov) | September 5, 2018 | 8/8/2018 | A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd) | A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd) | Primary IgA Nephropathy | Drug: Nefecon;Drug: Placebo oral capsule | Calliditas Therapeutics AB | NULL | Active, not recruiting | 18 Years | N/A | All | 365 | Phase 3 | United States;Argentina;Australia;Belarus;Belgium;Canada;Czechia;Finland;France;Germany;Greece;Italy;Korea, Republic of;Poland;Spain;Sweden;Taiwan;Turkey;United Kingdom |
| 64 | EUCTR2018-000075-33-SE (EUCTR) | 03/09/2018 | 03/05/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;China;Sweden;Korea, Republic of | ||
| 65 | EUCTR2017-004902-16-PL (EUCTR) | 27/08/2018 | 18/07/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). - NefIgArd | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada | ||
| 66 | EUCTR2018-000075-33-ES (EUCTR) | 01/08/2018 | 21/05/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 434 | Phase 3 | United States;Slovakia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Sweden | ||
| 67 | EUCTR2017-004902-16-FI (EUCTR) | 18/07/2018 | 02/03/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 68 | EUCTR2018-000075-33-SK (EUCTR) | 21/06/2018 | 20/04/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of | ||
| 69 | EUCTR2017-004902-16-BE (EUCTR) | 18/06/2018 | 21/02/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 70 | EUCTR2018-000075-33-LT (EUCTR) | 15/06/2018 | 23/04/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Narsoplimab Product Code: OMS721 INN or Proposed INN: Narsoplimab Other descriptive name: MASP-2 Antibody, OMS00620646, OMS620646 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Thailand;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 71 | EUCTR2018-000075-33-HU (EUCTR) | 07/06/2018 | 29/03/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 434 | Phase 3 | United States;Hungary;Canada;Australia | ||
| 72 | EUCTR2017-004902-16-CZ (EUCTR) | 04/06/2018 | 12/02/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 73 | EUCTR2017-004902-16-GB (EUCTR) | 29/05/2018 | 22/06/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 74 | EUCTR2017-000891-27-NL (EUCTR) | 25/05/2018 | 09/04/2018 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 75 | EUCTR2017-000891-27-DK (EUCTR) | 25/05/2018 | 11/04/2018 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 76 | EUCTR2017-000891-27-BE (EUCTR) | 22/05/2018 | 19/03/2018 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 77 | EUCTR2017-004902-16-ES (EUCTR) | 09/04/2018 | 02/03/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Korea, Republic of;Sweden | ||
| 78 | EUCTR2017-000891-27-DE (EUCTR) | 06/04/2018 | 24/11/2017 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Belgium;Singapore;Germany;Norway;Japan;Sweden;United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil | ||
| 79 | EUCTR2017-004902-16-SE (EUCTR) | 28/03/2018 | 13/02/2018 | A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy. | A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: Nefecon INN or Proposed INN: BUDESONIDE Other descriptive name: Nefecon | Calliditas Therapeutics AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of | ||
| 80 | EUCTR2017-000891-27-SE (EUCTR) | 19/02/2018 | 17/10/2017 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden;Hungary;Czech Republic;United Kingdom;Turkey;Finland;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;Jordan;France;India;Italy;Colombia;Israel;Lebanon;Spain;Thailand;Hong Kong;Taiwan;Philippines;United States | ||
| 81 | NCT03608033 (ClinicalTrials.gov) | February 16, 2018 | 21/6/2018 | Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN) | IgA Nephropathy | Biological: OMS721;Other: Vehicle (D5W or saline) | Omeros Corporation | NULL | Recruiting | 18 Years | N/A | All | 450 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Hungary;Lithuania;Poland;Slovakia;Spain |
| 82 | NCT03373461 (ClinicalTrials.gov) | February 7, 2018 | 30/11/2017 | Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation | An Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients | IgA Nephropathy | Drug: LNP023;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 112 | Phase 2 | Argentina;Australia;Belgium;Brazil;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hong Kong;India;Israel;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Singapore;Sweden;Taiwan;Thailand;Turkey;United Kingdom;Hungary;Italy;Spain;United States |
| 83 | EUCTR2017-000891-27-FI (EUCTR) | 09/01/2018 | 23/11/2017 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Hong Kong;Taiwan;Spain;Thailand;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 84 | EUCTR2017-000891-27-GB (EUCTR) | 21/11/2017 | 06/10/2017 | A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy | An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients | Primary IgA Nephropathy MedDRA version: 20.0;Level: HLGT;Classification code 10029149;Term: Nephropathies;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: LNP023 INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;Philippines;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 85 | EUCTR2016-002262-31-GB (EUCTR) | 17/03/2017 | 27/01/2017 | A Clinical Trial to Examine the Effects of the Drug Atacicept in Patients with Nephropathy (Diabetic Kidney Disease). | A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy | IgA Nephropathy MedDRA version: 20.1;Level: PT;Classification code 10061835;Term: Diabetic nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;France;Taiwan;Czech Republic;Spain;Belgium;Singapore;Israel;Japan;Italy;United Kingdom;Korea, Republic of | ||
| 86 | JPRN-JapicCTI-183956 | 21/2/2017 | 14/05/2018 | A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy | A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy | IgA Nephropathy | Intervention name : Atacicept25mg INN of the intervention : Atacicept Dosage And administration of the intervention : Subject will receive Atacicept 25 milligram (mg) once weekly as a subcutaneous (SC) injection for 72 weeks. Intervention name : Atacicept75mg INN of the intervention : Atacicept Dosage And administration of the intervention : Subject will receive Atacicept 75 mg once weekly as an SC injection for 72 weeks. Intervention name : Atacicept25mg INN of the intervention : Atacicept Dosage And administration of the intervention : Subject will receive Atacicept 25 mg once weekly as an SC injection for 156 weeks. Intervention name : Atacicept75mg INN of the intervention : Atacicept Dosage And administration of the intervention : Subject will receive Atacicept 75 mg once weekly as an SC injection for 156 weeks. Intervention name : Atacicept150mg INN of the intervention : Atacicept Dosage And administration of the intervention : Subject will receive Atacicept 150 mg once weekly as an SC injection for 156 weeks. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Subject will receive matching Placebo to atacicept once weekly as an SC injection for 72 weeks. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Subject will receive matching Placebo to atacicept once weekly as an SC injection for 156 weeks. | Merck Biopharma Co., Ltd. | NULL | complete | 20 | BOTH | 60 | Phase 2 | Japan, Europe | |
| 87 | NCT02808429 (ClinicalTrials.gov) | January 31, 2017 | 16/6/2016 | Efficacy and Safety of Atacicept in IgA Nephropathy | A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy | IgA Nephropathy | Drug: Placebo;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Completed | 18 Years | N/A | All | 16 | Phase 2 | United States;Japan;United Kingdom;Germany |
| 88 | NCT02942381 (ClinicalTrials.gov) | September 13, 2016 | 14/10/2016 | A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy | IgA Patients;Hydroxychloroquine | Drug: Hydroxychloroquine Sulfate;Drug: Placebo | Peking University First Hospital | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 2 | China | |
| 89 | NCT02605525 (ClinicalTrials.gov) | December 31, 2015 | 12/11/2015 | Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy | A Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion With Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects With Immunoglobulin A Nephropathy (IgAN) | Immunoglobulin A Nephropathy | Biological: SM101;Other: Placebo | Baxalta now part of Shire | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | NULL |
| 90 | EUCTR2014-001365-26-IT (EUCTR) | 05/06/2015 | 23/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 91 | EUCTR2014-001365-26-ES (EUCTR) | 27/05/2015 | 27/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 92 | EUCTR2014-001365-26-SE (EUCTR) | 11/05/2015 | 25/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 18.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2/3 | Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 93 | EUCTR2014-001365-26-HU (EUCTR) | 11/05/2015 | 25/03/2015 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Belarus;Portugal;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 94 | EUCTR2014-001365-26-DE (EUCTR) | 02/02/2015 | 07/08/2014 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 19.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 95 | NCT02052219 (ClinicalTrials.gov) | October 2014 | 29/1/2014 | BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 96 | NCT02112838 (ClinicalTrials.gov) | October 2014 | 10/4/2014 | Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy | A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy | IGA Nephropathy | Drug: Fostamatinib 150 mg;Drug: Fostamatinib 100 mg;Drug: Placebo | Rigel Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 76 | Phase 2 | United States;Austria;Germany;Hong Kong;Taiwan;United Kingdom;Singapore;Switzerland |
| 97 | EUCTR2014-000331-16-AT (EUCTR) | 25/08/2014 | 22/07/2014 | N/A | A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy - N/A | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Fostamatinib 100 mg tablet Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: FOSTAMATINIB DISODIUM Product Name: Fostamatinib 150 mg tablet Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: FOSTAMATINIB DISODIUM | Rigel Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Hong Kong;Taiwan;Singapore;Austria;United Kingdom;Switzerland | ||
| 98 | EUCTR2014-001365-26-CZ (EUCTR) | 21/08/2014 | 22/05/2014 | A study to evaluate the safety and efficacy of Blisibimod in IgA Nephropathy | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Blisibimod Injection Product Code: A-623 or AMG 623 INN or Proposed INN: blisibimod | Anthera Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Philippines;Taiwan;Hong Kong;Spain;Thailand;United Kingdom;Italy;Hungary;Czech Republic;Canada;Malaysia;Singapore;Germany;Japan;Sweden;Korea, Republic of | ||
| 99 | EUCTR2014-000331-16-GB (EUCTR) | 28/07/2014 | 08/05/2014 | N/A | A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy - N/A | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Fostamatinib 100 mg tablet Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: FOSTAMATINIB DISODIUM Product Name: Fostamatinib 150 mg tablet Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: FOSTAMATINIB DISODIUM | Rigel Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 92 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hong Kong;Taiwan;Singapore;Austria;Switzerland;United Kingdom | ||
| 100 | NCT02062684 (ClinicalTrials.gov) | June 2013 | 12/2/2014 | BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration | A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy | IgA Nephropathy | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 57 | Phase 2/Phase 3 | Czechia;Germany;Hong Kong;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand;United Kingdom;Canada;Czech Republic;Italy;Russian Federation;Spain |
| 101 | EUCTR2012-001923-11-ES (EUCTR) | 09/01/2013 | 29/11/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 14.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 102 | EUCTR2012-001923-11-NL (EUCTR) | 18/12/2012 | 19/10/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 16.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
| 103 | EUCTR2012-001923-11-DE (EUCTR) | 10/12/2012 | 22/08/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 104 | NCT01738035 (ClinicalTrials.gov) | December 2012 | 25/7/2012 | The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease | A Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease | Primary IgA Nephropathy | Drug: NEFECON;Other: Placebo | Pharmalink AB | NULL | Completed | 18 Years | N/A | Both | 150 | Phase 2 | Belgium;Czech Republic;Denmark;Finland;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 105 | EUCTR2012-001923-11-SE (EUCTR) | 21/11/2012 | 03/09/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 106 | EUCTR2012-001923-11-BE (EUCTR) | 19/11/2012 | 22/08/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 107 | EUCTR2012-001923-11-GB (EUCTR) | 06/11/2012 | 28/09/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 108 | EUCTR2012-001923-11-DK (EUCTR) | 05/11/2012 | 14/09/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 109 | EUCTR2012-001923-11-CZ (EUCTR) | 24/10/2012 | 16/08/2012 | A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 110 | EUCTR2012-001923-11-FI (EUCTR) | 17/10/2012 | 15/08/2012 | A study to assess if two different doses of Nefecon (budesonide) compared to placebo are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial | Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon INN or Proposed INN: BUDESONIDE | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 111 | EUCTR2012-001923-11-IT (EUCTR) | 27/09/2012 | 24/09/2012 | A study to assess if two different doses of Nefecon taken as a capsule are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease | A Multicentre, Interventional treatment, Randomised, Double-Blind, Single Group Assignment Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in primary IgA nephropathy patients at risk of developing end-stage renal disease - NEFIGAN Trial | Primary IgA nephropathy at risk of developing end stage renal disease MedDRA version: 15.0;Level: LLT;Classification code 10037034;Term: Proteinuria present;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nefecon Product Code: A07EA06 INN or Proposed INN: BUDESONIDE | CROWN OY | NULL | Not Recruiting | Female: yes Male: yes | 200 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 112 | NCT01560052 (ClinicalTrials.gov) | May 5, 2012 | 15/3/2012 | Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study) | Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study | IgA Glomerulonephritis | Drug: methylprednisolone;Drug: Placebo | The George Institute | Peking University First Hospital | Completed | 18 Years | N/A | All | 503 | N/A | Australia;Canada;China;Hong Kong;India;Malaysia |
| 113 | NCT01224028 (ClinicalTrials.gov) | November 2010 | 18/10/2010 | A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients | Double-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA Nephropathy | IgA Nephropathy | Drug: Tacrolimus;Drug: Placebo | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Completed | 18 Years | 70 Years | Both | 40 | Phase 2 | Korea, Republic of |
| 114 | ChiCTR-TRC-10000776 | 2010-02-27 | 2010-02-10 | A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy | A Study on the Efficacy and Safety of Telmisartan, Clopidogrelin and Leflunomide in patients with IgA nephropathy | lgA nephropathy;ICD:N03.8 | 1:Telmisartan+ Clopidogrelin placebo + Leflunomide placebo ;2:Telmisartan + Clopidogrelin+ Leflunomide placebo ;3:Telmisartan + Clopidogrelin placebo + Leflunomide;4:Telmisartan + Clopidogrelin + Leflunomide; | Chinese General Hospital of PLA | NULL | Completed | 18 | 55 | Both | 1:100;2:100;3:100;4:100; | China | |
| 115 | ChiCTR-TRC-10000824 | 2010-01-01 | 2010-04-06 | the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients | Multicenter, randomized, double-blind, placebo-controlled clinical research of the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients | IgA Nephropathy | the control group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid; placebos 2.5g tid; The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d; If patients with hypertension(target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead; if still poorly controlled, combined with Betaloc 12.5mg, bid;the treatment group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid; Fufang Shenyan Tablets 2.5g tid; The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d; If patients with hypertension (target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead; if still poorly controlled, combined with Betaloc 12.5mg, bid; | The First Affiliated Hospital of Xi'an Jiaotong University Medical College | NULL | Completed | 18 | 65 | Both | the control group:60;the treatment group:60; | China | |
| 116 | NCT01879514 (ClinicalTrials.gov) | January 2010 | 25/3/2013 | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath | IgA Nephropathy | Drug: Chinese Herb Prescription Granule plus prednisone;Drug: Placebo | Shanghai University of Traditional Chinese Medicine | Shanghai Sixth People's Hospital;RenJi Hospital | Recruiting | 18 Years | 60 Years | Both | 200 | N/A | China |
| 117 | NCT00870493 (ClinicalTrials.gov) | April 2009 | 26/3/2009 | Aliskiren for Immunoglobulin A (IgA) Nephropathy | The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study | IgA Nephropathy | Drug: Aliskiren;Drug: Placebo | Chinese University of Hong Kong | NULL | Completed | 18 Years | 65 Years | Both | 22 | Phase 3 | Hong Kong |
| 118 | NCT00549692 (ClinicalTrials.gov) | November 2007 | 25/10/2007 | Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy | Minimization, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA Nephropathy | IgA Nephropathy | Drug: Omega-3 fatty acid ethylester90 | Kuhnil Pharmaceutical Co., Ltd. | Pronova BioPharma ASA | Completed | 18 Years | N/A | Both | 152 | Phase 3 | Korea, Republic of |
| 119 | NCT00426348 (ClinicalTrials.gov) | May 2007 | 23/1/2007 | A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy | A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy | Glomerulonephritis;IGA Nephropathy | Drug: Valsartan;Drug: Probucol;Drug: Placebo | Guangdong General Hospital | NULL | Completed | 18 Years | 60 Years | Both | 75 | Phase 4 | China |
| 120 | NCT00318474 (ClinicalTrials.gov) | January 2002 | 24/4/2006 | Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy | A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy | IgA Nephropathy | Drug: Mycophenolate Mofetil (MMF);Drug: MMF Placebo;Drug: ACEi;Drug: FOS | St. Joseph's Hospital and Medical Center, Phoenix | NULL | Terminated | 7 Years | 70 Years | All | 184 | Phase 3 | United States |