222. 一次性ネフローゼ症候群 Primary nephrotic syndrome Clinical trials / Disease details
臨床試験数 : 285 / 薬物数 : 285 - (DrugBank : 108) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 191
| 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 | NCT04629248 (ClinicalTrials.gov) | June 25, 2021 | 27/10/2020 | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy | A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy | Primary Membranous Nephropathy | Drug: Obinutuzumab;Drug: Tacrolimus;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Diphenhydramine | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 75 Years | All | 140 | Phase 3 | United States;Argentina;Brazil;China;France;Israel;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine;Peru |
| 2 | NCT03466801 (ClinicalTrials.gov) | March 20, 2018 | 13/1/2018 | The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I. | The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I. | Idiopathic Membranous Nephropathy | Drug: Prednisone;Drug: MP and CTX | Wenhu Liu | NULL | Terminated | 18 Years | 80 Years | All | 6 | N/A | China |
| 3 | EUCTR2013-000226-55-NL (EUCTR) | 04/03/2015 | 24/06/2014 | SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY | European Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN | Primary membranous nephropathy MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Tacrolimus Product Name: TACROLIMUS INN or Proposed INN: TACROLIMUS Other descriptive name: TACROLIMUS Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE ACETATE Trade Name: cyclophosphamide Product Name: cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE | Fundacion Renal Iñigo Alvarez Toledo | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 175 | Spain;Netherlands | |||
| 4 | NCT01955187 (ClinicalTrials.gov) | January 2014 | 19/9/2013 | Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous Nephropathy | European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) | MEMBRANOUS NEPHROPATHY | Drug: TACROLIMUS;Drug: RITUXIMAB;Drug: METHYLPREDNISOLONE;Drug: CYCLOPHOSPHAMIDE | Hospital Universitario 12 de Octubre | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz;Hospital Universitario Fundación Alcorcón;Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre;Biobanco REDinREN;ERA-EDTA;REDinREN;Sociedad Española de Nefrología;Fundación de Investigación Biomédica - Hospital Universitario de La Princesa;University Hospital, Aachen | Completed | 18 Years | N/A | All | 86 | Phase 3 | Spain |
| 5 | NCT03018535 (ClinicalTrials.gov) | January 2012 | 9/1/2017 | Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy | A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy | Glomerulonephritis, Membranous | Drug: Rituximab;Drug: Methylprednisolone;Drug: Cyclophosphamide | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | University of Bari;Azienda Ospedaliera Brotzu;University of Messina;University of Milan;Universita di Verona;University of Chieti;University of Bologna;Azienda Sanitaria Locale Roma E;Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi;Regione Piemonte;University of Modena and Reggio Emilia;University of Pisa;University of Milano Bicocca;Humanitas Hospital, Italy;Azienda Ospedaliera Universitaria Policlinico;Fondazione Salvatore Maugeri;University of Bern;University of Alberta;Istituto Giannina Gaslini | Active, not recruiting | 18 Years | N/A | All | 76 | Phase 3 | Italy |
| 6 | ChiCTR-TRC-11001454 | 2011-08-01 | 2011-08-08 | Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial | Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial | minimal change disease in adults;ICD10:N04.001 | Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape;Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape; | Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Completed | Both | Group A:60;Group B:60; | China | |||
| 7 | ChiCTR-ONC-12002809 | 2009-01-01 | 2012-05-24 | Clinical Study of Prediction of Glucocorticoid Efficacy by cytokins in Patients with Primary Nephrotic Syndrome | Clinical Study of Prediction of Glucocorticoid Efficacy by cytokins in Patients with Primary Nephrotic Syndrome | Idiopathic nephrotic syndrome | 1:Given methylprednisolone according to the status of the patients ; | The First Affiliated Hospital of Dalian Medical University | NULL | Completed | 18 | 75 | Both | 1:90; | China | |
| 8 | ChiCTR1900022518 | 2004-04-01 | 2019-04-15 | Clinical trial for corticosteroids monotherapy in the treatment of seronegative hepatitis B virus-associated membranous nephropathy. | Efficacy and safety of corticosteroids in 26 cases of seronegative hepatitis B virus-associated membranous nephropathy | Seronegative Hepatitis B Virus-associated Membranous Nephropathy | Case series:give corticosteroids(Methylprednisolone); | Tianjin Hospital | NULL | Completed | Both | Case series:26; | China | |||
| 9 | NCT00135967 (ClinicalTrials.gov) | May 2002 | 25/8/2005 | Mycophenolate Mofetil in Membranous Nephropathy | Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study | Glomerulonephritis, Membranous | Drug: mycophenolate mofetil orally 1000 mg twice a day (BID);Drug: prednisone 0,5 mg/kg orally on alternate days;Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9 | Radboud University | Hoffmann-La Roche | Completed | 18 Years | 75 Years | Both | 30 | Phase 2/Phase 3 | Netherlands |