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 | NCT05667909 (ClinicalTrials.gov) | June 2023 | 7/12/2022 | Prognostic Model of Rituximab in the Treatment of MN | Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Rituximab | Idiopathic Membranous Nephropathy | Drug: Rituximab | Qianfoshan Hospital | NULL | Not yet recruiting | 18 Years | 75 Years | All | 50 | NULL | |
| 2 | NCT05532111 (ClinicalTrials.gov) | September 1, 2022 | 1/9/2022 | Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical Trial | Efficacy and Safety of Rituximab Combined With Tacrolimus in the Treatment of Intermediate-to-high Risk Primary Membranous Nephropathy: A Randomized Clinical Trial | Efficacy and Safety | Drug: Rituximab combined with tacrolimus induction + rituximab maintenance;Drug: Rituximab combined with tacrolimus induction + tacrolimus maintenance;Drug: Glucocorticoid combined with cyclophosphamide induction + maintenance | RenJi Hospital | NULL | Not yet recruiting | 18 Years | 75 Years | All | 60 | N/A | NULL |
| 3 | ChiCTR2200057381 | 2022-03-01 | 2022-03-10 | Efficacy and safety of low-dose rituximab in the treatment of membranous nephropathy | Efficacy and safety of low-dose rituximab in the treatment of membranous nephropathy | membranous nephropathy | rituximab group:rituximab;control:hormone combined with cyclophosphamide; | Peking University Third Hospital | NULL | Pending | 18 | 80 | Both | rituximab group:68;control:135; | N/A | China |
| 4 | EUCTR2021-004864-81-IT (EUCTR) | 17/12/2021 | 17/09/2021 | Proposta di studio per valutare l’efficacia di Obinutuzumab, un anticorpo anti-CD20, in pazienti con nefropatia membranosa intolleranti, resistenti o dipendenti alla terapia con Rituximab (studio ORION) | Proposta di studio per valutare l’efficacia di Obinutuzumab, un anticorpo anti-CD20, in pazienti con nefropatia membranosa intolleranti, resistenti o dipendenti alla terapia con Rituximab (studio ORION) - Obinutuzumab in primary MN | PRIMARY MEMBRANOUS NEPHROPATHY MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12] | Trade Name: GAZYVARO - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 1000MG/40ML - 1 FLACONCINO Product Name: GAZYVARO Product Code: [L01XC15] INN or Proposed INN: Obitunuzumab Trade Name: OMNIPAQUE - 300 MG I/ML SOLUZIONE INIETTABILE FLACONE IN POLIPROPILENE DA 50 ML Product Name: OMNIPAQUE Product Code: [Ioexolo] INN or Proposed INN: ioexolo | IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 5 | ChiCTR2100049205 | 2021-08-01 | 2021-07-25 | A prospective randomized controlled multicenter clinical study on the treatment strategy of primary membranous nephropathy in the high-risk phase | A prospective randomized controlled multicenter clinical study on the treatment strategy of primary membranous nephropathy in the high-risk phase | Membranous nephropathy | Group B:Cyclophosphamide combined with glucocorticoids;Group C:Low-dose Cyclophosphamide, glucocorticoid combined with rituximab;Group A:Rituximab; | Shanghai Dongfang Hospital | NULL | Recruiting | 18 | 75 | Both | Group B:30;Group C:30;Group A:30; | China | |
| 6 | NCT04745728 (ClinicalTrials.gov) | April 14, 2021 | 4/2/2021 | Different Immunosuppressive Treatment in iMN | Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort | Idiopathic Membranous Nephropathy | Drug: Prednisone;Drug: Cyclophosphamide;Drug: Rituximab | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 200 | Phase 3 | China |
| 7 | NCT04743739 (ClinicalTrials.gov) | April 14, 2021 | 30/1/2021 | Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN | A Multicenter Randomized Controlled Trial of Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of Idiopathic Membranous Nephropathy | Idiopathic Membranous Nephropathy | Drug: Rituximab;Drug: cyclosporine | Peking Union Medical College Hospital | Beijing Tongren Hospital;Chinese Academy of Medical Sciences, Fuwai Hospital;The Luhe Teaching Hospital of the Capital Medical University;The Seventh Affiliated Hospital, Sun Yat-sen University;First Affiliated Hospital of Xinjiang Medical University;Nanyang Nanshi Hospital of Henan University;Shanghai Fosun Pharmaceutical Development Co, Ltd. | Recruiting | 18 Years | 80 Years | All | 126 | Phase 3 | China |
| 8 | ChiCTR2100042674 | 2021-01-18 | 2021-01-26 | Standard dose Rituximab for membranous nephropathy: a multi-center prospective cohort study | Standard dose Rituximab for membranous nephropathy: a multi-center prospective cohort study | syndrome disease | experimental group:RTX treatment; | Jiangsu Province People's Hospital | NULL | Recruiting | 18 | 75 | Male | experimental group:65; | Phase 4 | China |
| 9 | NCT03970577 (ClinicalTrials.gov) | July 29, 2020 | 15/4/2019 | RItuximab From the FIRst Episode of Idiopathic Nephrotic Syndrome | Rituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled Trial | Minimal Change Nephrotic Syndrome (MCNS) | Drug: Rituximab;Drug: Prednisone | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | N/A | All | 148 | Phase 2 | France |
| 10 | ChiCTR2000032523 | 2020-06-01 | 2020-05-01 | Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial. | Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial | membranous nephropathy | experimental group:rituximab;control group:tacrolimus; | Xinqiao Hospital | NULL | Pending | 18 | 80 | Both | experimental group:40;control group:40; | Phase 4 | China |
| 11 | ChiCTR2000033540 | 2020-06-01 | 2020-06-04 | Prospective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous Nephropathy | Prospective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous Nephropathy | Membranous Nephropathy | experimental group:Rituximab 600mg iv, and supportive treatment;control group:Supportive treatment according to KDIGO guideline; | Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | NULL | Recruiting | 18 | 70 | Both | experimental group:19;control group:19; | Phase 4 | China |
| 12 | ChiCTR2000040799 | 2020-05-20 | 2020-12-10 | Prospective study of rituximab combined with low-dose hormone in the treatment of idiopathic membranous nephropathy | Prospective study of rituximab combined with low-dose hormone in the treatment of idiopathic membranous nephropathy | idiopathic membranous nephropathy | Single arm:Rituximab; | The First Affiliated Hospital, Sun Yat-Sen University | NULL | Recruiting | 18 | Both | Single arm:50; | Phase 4 | China | |
| 13 | EUCTR2019-001734-34-NL (EUCTR) | 07/04/2020 | 22/08/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, open-label, two-arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Netherlands;Germany;China | ||
| 14 | NCT03804359 (ClinicalTrials.gov) | January 14, 2020 | 11/1/2019 | Personalized Medicine for Membranous Nephropathy | Personalized Medicine for Membranous Nephropathy | Idiopathic Membranous Nephropathy | Drug: Rituximab | Centre Hospitalier Universitaire de Nice | NULL | Recruiting | 18 Years | N/A | All | 64 | Phase 2 | France |
| 15 | 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 |
| 16 | NCT04154787 (ClinicalTrials.gov) | November 23, 2019 | 8/10/2019 | Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy | A Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous Nephropathy | Glomerulonephritis, Membranous | Drug: LNP023;Drug: Rituximab | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 37 | Phase 2 | Argentina;China;Czechia;Germany;India;Netherlands;Spain;Taiwan;United Kingdom;France;Singapore;United States |
| 17 | EUCTR2019-001734-34-ES (EUCTR) | 12/11/2019 | 04/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Rituximab INN or Proposed INN: RITUXIMAB | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | 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;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 18 | EUCTR2019-001734-34-DE (EUCTR) | 30/10/2019 | 12/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, open-label, two arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Czech Republic;Argentina;Singapore;Germany;Netherlands;China | ||
| 19 | EUCTR2019-001734-34-FR (EUCTR) | 23/10/2019 | 13/09/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 20 | EUCTR2019-001734-34-GB (EUCTR) | 23/09/2019 | 07/08/2019 | Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy. | A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. | Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India | ||
| 21 | NCT03763643 (ClinicalTrials.gov) | July 1, 2019 | 7/8/2018 | PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant | PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant | Focal Segmental Glomerulosclerosis | Drug: Rituximab;Procedure: Plasmapheresis | University of Minnesota | United States Department of Defense | Recruiting | 1 Year | 65 Years | All | 60 | Early Phase 1 | United States |
| 22 | EUCTR2018-004611-50-GB (EUCTR) | 14/06/2019 | 11/04/2019 | The Use of Rituximab IN treatment of immune-mediated Glomerulonephritis (TURING) | A randomised, two-arm (1:1 ratio), double blind, placebo controlled phase III trial to assess the efficacy, safety, cost and cost-effectiveness of rituximab in treating de novo or relapsing NS in patients with MCD/FSGS (TURING) - TURING | Minimal Change Disease (MCD) and Focal segmental glomerulosclerosis (FSGS) | Product Name: Rituximab INN or Proposed INN: Rituximab | Cambridge University Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 23 | EUCTR2018-003437-15-FR (EUCTR) | 03/04/2019 | 27/02/2019 | Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome | Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome - RIFIREINS | Minimal Change Nephrotic Syndrome (MCNS) MedDRA version: 20.0;Level: LLT;Classification code 10029168;Term: Nephrotic syndrome with lesion of minimal change glomerulonephritis;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 24 | NCT03298698 (ClinicalTrials.gov) | August 22, 2018 | 24/8/2017 | Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome | Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Unresponsive to 8 Weeks of High Dose Prednisone | Idiopathic Nephrotic Syndrome;Minimal Change Disease;Focal Segmental Glomerulosclerosis | Drug: Rituximab;Drug: Prednisone | Radboud University | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 3 | Netherlands |
| 25 | NCT05679336 (ClinicalTrials.gov) | May 1, 2018 | 28/11/2022 | Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy | Rituximab, Cyclophosphamide, and Corticosteroids at Low Cumulative Doses to Induce Remission in Primary Membranous Nephropathy | Membranous Nephropathy - PLA2R Induced | Drug: Rituximab, Cyclophosphamide, and Corticosteroids | St. Petersburg State Pavlov Medical University | NULL | Recruiting | 18 Years | 75 Years | All | 40 | N/A | Russian Federation |
| 26 | NCT03180723 (ClinicalTrials.gov) | July 1, 2017 | 3/6/2017 | Effect of Rituximab in Treatment of Membranoproliferative Glomerulonephritis | Effect of Rituximab in Treatment of Primary Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis | Drug: Rituximab;Drug: Cyclosporin | Assiut University | NULL | Not yet recruiting | 18 Years | N/A | All | 30 | Phase 3 | NULL |
| 27 | NCT02966717 (ClinicalTrials.gov) | August 2016 | 30/10/2016 | Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD) | The Clinical Study of Rituximab Combined With Mesenchymal Stem Cells in the Treatment of Primary Nephrotic Syndrome (3-4 Stage of Chronic Kidney Disease) | Renal Insufficiency, Chronic;Nephrotic Syndrome | Drug: Rituximab;Drug: conventional therapy;Drug: Mesenchymal stem cells | Zhujiang Hospital | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 116 | Phase 2 | China |
| 28 | ChiCTR-IPR-16008527 | 2016-06-01 | 2016-05-24 | Rituximab in the treatment of refractory membranous nephropathy: a multicenter, randomized, controlled clinical study | Rituximab in the treatment of resistant membranous nephropathy: a multicenter, randomized, controlled clinical study | Membranous nephropathy | CsA group:oral CsA and glucosteroid;RTX group:intravenous RTX;CTX:Intravenous cyclophosphamide and glucosteroid; | Ruijin Hospital, affiliated to Shanghai Jiaotong University, School of medicine | NULL | Completed | 18 | 70 | Both | CsA group:60;RTX group:60;CTX:60; | Phase 4 | China |
| 29 | JPRN-UMIN000022150 | 2016/04/30 | 01/05/2016 | The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome. | The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome. - The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome. | primary nephrotic syndrome | rituximab | Tokyo Metropolitan Geriatric Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 50 | Not applicable | Japan |
| 30 | 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 | |||
| 31 | 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 |
| 32 | NCT01573533 (ClinicalTrials.gov) | October 2013 | 5/4/2012 | A Pilot Study to Assess the Efficacy of Rituximab Therapy in Treatment Resistant FSGS | A Pilot Study to Assess the Efficacy of Rituximab Therapy in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS): Integrating an Assessment of the Relevance of suPAR and Activation of Podocyte ß3 Integrin | Primary Focal Segmental Glomerulosclerosis | Biological: Rituximab | Mayo Clinic | University Health Network, Toronto;National Institutes of Health (NIH);Genentech, Inc.;Rush University Medical Center;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 6 Years | 80 Years | All | 9 | Phase 2 | United States;Canada |
| 33 | EUCTR2011-006115-59-IT (EUCTR) | 11/06/2012 | 08/06/2012 | A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) | A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) - GNM-2011 | MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hyp MedDRA version: 14.1;Level: PT;Classification code 10018372;Term: Glomerulonephritis membranous;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Trade Name: MABTHERA*EV 1FL 50ML 500MG Trade Name: URBASON*IM EV 1F 250MG+1F 5ML Trade Name: MEDROL*10CPR DIV 4MG Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG | AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 34 | NCT01164098 (ClinicalTrials.gov) | February 2012 | 15/7/2010 | Rituximab to Prevent Recurrence of Proteinuria | The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS | FSGS;Proteinuria | Drug: Rituximab | George W. Burke | Genentech, Inc.;National Institutes of Health (NIH);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Terminated | 7 Years | 65 Years | All | 30 | Phase 3 | United States |
| 35 | NCT01508468 (ClinicalTrials.gov) | January 17, 2012 | 9/12/2011 | Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy | Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin);Drug: experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab) | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 80 | Phase 3 | France |
| 36 | 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 |
| 37 | NCT01180036 (ClinicalTrials.gov) | November 2011 | 10/8/2010 | MEmbranous Nephropathy Trial Of Rituximab | A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: Rituximab;Drug: Cyclosporine | Mayo Clinic | Columbia University;University of British Columbia;Ohio State University;Stanford University;University of Washington;University of Michigan;University of Alabama at Birmingham;Case Western Reserve University;The Cleveland Clinic;University of Kansas Medical Center;University of Manchester;University Health Network, Toronto;University of Toronto;CHU de Quebec-Universite Laval;Washington University School of Medicine;Florida International University;University of Mississippi Medical Center;NYU Langone Health;Medical College of Wisconsin;University of Arizona;Sunnybrook Health Sciences Centre;Applied Health Research Centre;Fulk Family Foundation | Completed | 18 Years | 80 Years | All | 130 | Phase 2/Phase 3 | United States;Canada |
| 38 | JPRN-UMIN000005231 | 2011/03/01 | 10/03/2011 | Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS) | Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS) - Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS) | steroid dependent and frequently relapsing minimal change nephrotic syndrome | rituximab 375mg/m2 single-dose 1 time/6months 24 months follow up | Department of Medicine, Kidney Center, Tokyo Women's Medical University | NULL | Complete: follow-up complete | 20years-old | 60years-old | Male and Female | 50 | Phase 3 | Japan |
| 39 | NCT00977977 (ClinicalTrials.gov) | December 22, 2010 | 15/9/2009 | Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy | Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy | Nephrotic Syndrome;Proteinuria;Autoimmune Disease;Glomerular Disease;Membranous Glomerulonephritis | Drug: Rituximab Infusion;Drug: Oral Cyclosporine | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 40 | EUCTR2008-006750-17-IT (EUCTR) | 14/04/2009 | 27/01/2009 | A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO | A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO | Nephrotic Syndrome secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS. MedDRA version: 9.1;Level: LLT;Classification code 10029171 MedDRA version: 9.1;Classification code 10058326 MedDRA version: 9.1;Classification code 10016832 | Trade Name: MABTHERA INN or Proposed INN: Rituximab Trade Name: MABTHERA INN or Proposed INN: Rituximab | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy | ||
| 41 | NCT00981838 (ClinicalTrials.gov) | April 2009 | 21/9/2009 | Rituximab in Multirelapsing Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS) | A Prospective, Sequential Study to Assess the Efficacy of Rituximab Therapy in Maintaining Remission of Nephrotic Syndrome After Steroid and Immunosuppressive Therapy Withdrawal in Patients With Steroid-dependant or Multirelapsing Minimal Change Disease or Focal Segmental Glomerulosclerosis (NEMO Study) | Nephrotic Syndrome | Drug: Rituximab | Mario Negri Institute for Pharmacological Research | Agenzia Italiana del Farmaco | Completed | 2 Years | 80 Years | Both | 24 | Phase 3 | Italy |
| 42 | NCT00550342 (ClinicalTrials.gov) | January 2008 | 26/10/2007 | Rituximab Treatment of Focal Segmental Glomerulosclerosis | Anti-CD20, Rituximab, for the Treatment of Recurrent or Primary Resistant Focal Segmental Glomerulosclerosis (FSGS) | Focal Segmental Glomerulosclerosis (FSGS) | Drug: rituximab | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Genentech, Inc.;Indiana University | Completed | 5 Years | 60 Years | All | 10 | Phase 2 | United States |
| 43 | NCT00405340 (ClinicalTrials.gov) | October 2006 | 29/11/2006 | Rituximab in the Treatment of Idiopathic Membranous Nephropathy | Rituximab in the Treatment of Idiopathic Membranous Nephropathy | Membranous Nephropathy | Drug: Rituximab | Mayo Clinic | Genentech, Inc. | Completed | 18 Years | N/A | Both | 20 | Phase 0 | United States |
| 44 | NCT00275613 (ClinicalTrials.gov) | November 2005 | 10/1/2006 | Pilot Study of Rituximab for Membranoproliferative Glomerulonephritis | Pilot Study of Rituximab for Membranoproliferative Glomerulonephritis | Glomerulonephritis, Membranoproliferative | Drug: Rituximab | Mayo Clinic | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 1 | United States |
| 45 | NCT00425217 (ClinicalTrials.gov) | August 2004 | 19/1/2007 | Rituximab in Membranous Nephropathy | The Use of Rituximab in the Treatment of Idiopathic Membranous Nephropathy | Membranous Nephropathy | Drug: Rituximab | Mayo Clinic | Genentech, Inc. | Completed | 18 Years | N/A | Both | 15 | Phase 2/Phase 3 | United States |