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

  
6 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004892-41-DE
(EUCTR)
16/11/202109/06/2021Atacicept 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 2Belarus;United States;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Malaysia;Belgium;Poland;Australia;Germany;Korea, Republic of
2EUCTR2020-004892-41-GR
(EUCTR)
06/09/202119/07/2021Atacicept 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 2United States;Belarus;Czechia;Greece;Turkey;United Kingdom;India;Czech Republic;Canada;Belgium;Malaysia;Poland;Australia;Germany;Korea, Republic of
3NCT04716231
(ClinicalTrials.gov)
May 18, 202111/1/2021Atacicept in Subjects With IgA NephropathyA 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 DiseaseBiological: Atacicept;Other: Placebo to match AtaciceptVera Therapeutics, Inc.NULLRecruiting18 YearsN/AAll105Phase 2United States;Australia;Belgium;Czechia;Germany;Greece;India;Korea, Republic of;Malaysia;Turkey;United Kingdom
4EUCTR2016-002262-31-GB
(EUCTR)
17/03/201727/01/2017A 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 KGaANULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;France;Taiwan;Czech Republic;Spain;Belgium;Singapore;Israel;Japan;Italy;United Kingdom;Korea, Republic of
5JPRN-JapicCTI-183956
21/2/201714/05/2018A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA NephropathyA Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy IgA NephropathyIntervention 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.NULLcomplete20BOTH60Phase 2Japan, Europe
6NCT02808429
(ClinicalTrials.gov)
January 31, 201716/6/2016Efficacy and Safety of Atacicept in IgA NephropathyA Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA NephropathyIgA NephropathyDrug: Placebo;Drug: Atacicept 25 mg;Drug: Atacicept 75 mgEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompleted18 YearsN/AAll16Phase 2United States;Japan;United Kingdom;Germany