66. IgA腎症 IgA nephropathy Clinical trials / Disease details
臨床試験数 : 255 / 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-004892-41-DE (EUCTR) | 16/11/2021 | 09/06/2021 | Atacicept in Subjects with IgA Nephropathy (ORIGIN) | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Vera Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 2 | Belarus;United States;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Malaysia;Belgium;Poland;Australia;Germany;Korea, Republic of | ||
| 2 | EUCTR2020-004892-41-GR (EUCTR) | 06/09/2021 | 19/07/2021 | Atacicept in Subjects with IgA Nephropathy (ORIGIN) | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - ORIGIN | IgA Nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept Product Code: VT-001 INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Vera Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 2 | United States;Belarus;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Belgium;Malaysia;Poland;Australia;Germany;Korea, Republic of | ||
| 3 | NCT04716231 (ClinicalTrials.gov) | May 18, 2021 | 11/1/2021 | Atacicept in Subjects With IgA Nephropathy | A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IGAN) | IgA Nephropathy;Berger Disease | Biological: Atacicept;Other: Placebo to match Atacicept | Vera Therapeutics, Inc. | NULL | Recruiting | 18 Years | N/A | All | 105 | Phase 2 | United States;Australia;Belgium;Czechia;Germany;Greece;India;Korea, Republic of;Malaysia;Turkey;United Kingdom |
| 4 | 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 | ||
| 5 | 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 | |
| 6 | 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 |