66. IgA腎症 IgA nephropathy Clinical trials / Disease details
臨床試験数 : 275 / 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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;Greece;Spain;Thailand;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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: 20.0;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: 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;Greece;Thailand;Spain;Italy;India;Australia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Sweden | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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;Greece;Thailand;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 14 | 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 | ||
| 15 | 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 |
| 16 | NCT02682407 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721 | A Phase 2 Study to Evaluate the Safety and Effect on Proteinuria of OMS721 in Subjects With IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, or C3 Glomerulopathy Including Dense Deposit Disease | IgAN;Lupus Nephritis;MN;C3 Glomerulopathy | Biological: OMS721 (narsoplimab) | Omeros Corporation | NULL | Recruiting | 18 Years | N/A | All | 54 | Phase 2 | United States;Hong Kong |