222. 一次性ネフローゼ症候群 Primary nephrotic syndrome Clinical trials / Disease details
臨床試験数 : 310 / 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
| 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 | ChiCTR2100048518 | 2021-10-31 | 2021-07-09 | A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy | A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy | idiopathic membranous nephropathy | low-dose multi-target group:No;tacrolimus combined with belimumab sequential group:No;intravenous cyclophosphamide pulse group:No; | The Second Affiliated Hospital of Xi'an Jiaotong University | NULL | Pending | 18 | 70 | Both | low-dose multi-target group:100;tacrolimus combined with belimumab sequential group:100;intravenous cyclophosphamide pulse group:100; | China | |
| 2 | NCT03949855 (ClinicalTrials.gov) | December 18, 2019 | 13/5/2019 | Belimumab With Rituximab for Primary Membranous Nephropathy | Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI) | Membranous Nephropathy;Nephrotic Syndrome | Drug: Belimumab;Drug: Placebo for Belimumab;Drug: Rituximab | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN);GlaxoSmithKline;PPD;Rho Federal Systems Division, Inc. | Recruiting | 18 Years | 75 Years | All | 124 | Phase 2 | United States;Canada |
| 3 | NCT01762852 (ClinicalTrials.gov) | April 2013 | 4/1/2013 | Efficacy and Safety Study of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy | BEL114674: A 2 Year Study of Efficacy and Safety of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy | Glomerulonephritis, Membranous | Drug: Belimumab 10 mg;Drug: Placebo | GlaxoSmithKline | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | United States;Australia;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 4 | EUCTR2011-000242-38-CZ (EUCTR) | 14/02/2013 | 13/11/2012 | A 2 year study to investigate belimumab in membranous nephropathy | BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;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] | Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 94 | United States;France;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;United Kingdom;Italy | |||
| 5 | EUCTR2011-000242-38-DE (EUCTR) | 09/01/2013 | 25/09/2012 | A 2 year study to investigate belimumab in membranous nephropathy | BEL114674: A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 16.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 94 | France;United States;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;Italy;United Kingdom | |||
| 6 | EUCTR2011-000242-38-ES (EUCTR) | 20/12/2012 | 22/10/2012 | A 2 year study to investigate belimumab in membranous nephropathy | A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 94 | United States;France;Czech Republic;Canada;Spain;Netherlands;Germany;United Kingdom;Italy | |||
| 7 | EUCTR2011-000242-38-IT (EUCTR) | 22/11/2012 | 11/12/2012 | A 2 year study to investigate belimumab in membranous nephropathy | A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA INN or Proposed INN: BELIMUMAB | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 94 | United States;Czech Republic;Canada;Spain;Germany;United Kingdom;Italy | |||
| 8 | EUCTR2011-000242-38-GB (EUCTR) | 01/11/2012 | 03/10/2012 | A 2 year study to investigate belimumab in membranous nephropathy | BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 15.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 94 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Canada;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 9 | EUCTR2012-000385-38-GB (EUCTR) | 18/05/2012 | 02/04/2012 | A study to investigate belimumab in IMGN | BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy | Idiopathic Membranous Glomerulonephropathy (IMGN) MedDRA version: 16.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: Belimumab | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom |