66. IgA腎症
［臨床試験数：199，薬物数：214（DrugBank：57），標的遺伝子数：32，標的パスウェイ数：128］
Searched query = "IgA nephropathy", "IgA nephritis", "Berger disease", "IgA-IgG nephropathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | NCT04578834 (ClinicalTrials.gov) | January 27, 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 | Not yet recruiting | 18 Years | N/A | All | 450 | Phase 3 | NULL |
| 2 | 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 | ||
| 3 | NCT04573478 (ClinicalTrials.gov) | December 1, 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 | Not yet recruiting | 18 Years | N/A | All | 320 | Phase 3 | NULL |
| 4 | 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 | |||
| 5 | 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;Japan;Korea, Republic of;Spain |
| 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 |
| 6 | 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 | ||
| 7 | NCT04291781 (ClinicalTrials.gov) | March 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 | NULL | Recruiting | 18 Years | 70 Years | All | 30 | Phase 2 | China |
| 8 | 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 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;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 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 |
| 11 | 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 | 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;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 12 | 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 | 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;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | ||
| 13 | 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 | 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 | ||
| 14 | 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 |
| 15 | 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 | ||
| 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 |
| 16 | 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 | United States;France;Philippines;Taiwan;Canada;Spain;Malaysia;Singapore;United Kingdom;Sweden | ||
| 17 | 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] | University of Leicester | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 21 | Phase 2 | United Kingdom | |||
| 18 | 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 | Recruiting | 18 Years | 65 Years | All | 30 | Phase 2 | United States;Canada;France;Malaysia;Philippines;Singapore;Spain;Sweden;Taiwan;United Kingdom |
| 19 | 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, 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 | Aduro Biotech, Inc. | NULL | Recruiting | 18 Years | N/A | All | 92 | Phase 1 | United States;United Kingdom |
| 20 | 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] | Alnylam Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;Philippines;Taiwan;Spain;United Kingdom;France;Canada;Malaysia;Singapore;Australia;Germany;Sweden;Korea, Republic of | |||
| 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 |
| 21 | 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 | ||
| 22 | 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] | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of | |||
| 23 | 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 |
| 24 | 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);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of | |||
| 25 | 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 | ||
| 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 |
| 26 | 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 | ||
| 27 | 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 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;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 28 | NCT03643965 (ClinicalTrials.gov) | September 5, 2018 | 8/8/2018 | Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy | 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 | Recruiting | 18 Years | N/A | All | 360 | 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 |
| 29 | 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 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;Thailand;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of | ||
| 30 | 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] | 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;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden | |||
| 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 |
| 31 | 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 | ||
| 32 | 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 | 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 | ||
| 33 | 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 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 | ||
| 34 | 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] | 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;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden | |||
| 35 | 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 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;Thailand;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 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 |
| 36 | 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 | ||
| 37 | 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 | 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 | ||
| 38 | 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 | ||
| 39 | 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 | 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;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 40 | 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 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 | Novartis Pharma AG | Not Recruiting | Female: yes Male: yes | 218 | Phase 2 | United States;Taiwan;Finland;Thailand;Italy;United Kingdom;France;Hungary;Czech Republic;Argentina;Belgium;Singapore;Australia;Denmark;Netherlands;Germany;Norway;China;Korea, Republic of;Sweden | ||
| 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 |
| 41 | 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] | 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;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Norway;Germany;Japan;Sweden | |||
| 42 | 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 | ||
| 43 | 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 | 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 | ||
| 44 | 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 | United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden | ||
| 45 | 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 | 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 | ||
| 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 |
| 46 | 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 |
| 47 | 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 | Recruiting | 18 Years | N/A | All | 146 | Phase 2 | United States;Argentina;Australia;Belgium;Brazil;China;Colombia;Czechia;Denmark;Finland;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;Norway;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;United Kingdom |
| 48 | 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;Taiwan;Hong Kong;Thailand;Spain;Lebanon;Israel;Colombia;Italy;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Norway;Japan;Sweden | ||
| 49 | 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 | ||
| 50 | 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 | ||
| 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 |
| 51 | 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 | |
| 52 | 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 |
| 53 | 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 | |
| 54 | NCT02605525 (ClinicalTrials.gov) | December 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 |
| 55 | 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;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 | ||
| 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 |
| 56 | 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 | ||
| 57 | 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;Phase 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 | ||
| 58 | 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;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 | ||
| 59 | 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 | ||
| 60 | 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 |
| 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 |
| 61 | 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 |
| 62 | 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 | ||
| 63 | 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 | ||
| 64 | 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] | Rigel Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 2 | United States;Hong Kong;Taiwan;Singapore;Austria;Switzerland;United Kingdom | |||
| 65 | 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 |
| 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 |
| 66 | 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 | |||
| 67 | 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 | |||
| 68 | 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] | Pharmalink AB | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 69 | 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 |
| 70 | 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 | |||
| 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 |
| 71 | 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 | ||
| 72 | 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 | |||
| 73 | 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 | ||
| 74 | 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 | ||
| 75 | 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 | |||
| 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 |
| 76 | 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 | |||
| 77 | NCT01560052 (ClinicalTrials.gov) | April 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 | Active, not recruiting | 18 Years | N/A | All | 503 | N/A | Australia;Canada;China;Hong Kong;India;Malaysia |
| 78 | 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 |
| 79 | 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 | |
| 80 | 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 | |
| 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 |
| 81 | 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 |
| 82 | 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 |
| 83 | 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 |
| 84 | 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 |
| 85 | 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 |