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 | NCT05398653 (ClinicalTrials.gov) | February 24, 2022 | 26/5/2022 | A Clinical Study of MIL62 in Primary Membranous Nephropathy | A Multicenter, Randomized, Controlled, Open Phase Ib/ ? Study Evaluating the Efficacy and Safety of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Primary Membranous Nephropathy. | Primary Membranous Nephropathy | Drug: MIL62;Drug: Cyclosporine | Beijing Mabworks Biotech Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 120 | Phase 1/Phase 2 | China |
| 2 | 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 |
| 3 | NCT04424862 (ClinicalTrials.gov) | June 9, 2020 | 7/6/2020 | Multitarget Therapy for Idiopathic Membranous Nephropathy | Multitarget Therapy for Idiopathic Membranous Nephropathy | Efficacy | Drug: Prednisone, ciclosporin and mycophenolate mofetil;Drug: Ponticelli Regimen | Beijing Friendship Hospital | NULL | Completed | 18 Years | 70 Years | All | 82 | Phase 4 | China |
| 4 | NCT03170323 (ClinicalTrials.gov) | July 1, 2018 | 26/5/2017 | Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy | A Prospective Randomized, Controlled Trial of Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy | Idiopathic Membranous Nephropathy | Drug: Mycophenolate Mofetil;Drug: Cyclosporins | Guangdong Provincial People's Hospital | NULL | Recruiting | 18 Years | N/A | All | 128 | Phase 4 | China |
| 5 | 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 |
| 6 | NCT02173106 (ClinicalTrials.gov) | June 2014 | 23/6/2014 | A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy | Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial | Idiopathic Membranous Nephropathy;Proteinuria;Spontaneous Remission;Steroid Nephropathy;Cyclosporin Overdose | Drug: steroid & Cyclosporin | Sun Yat-sen University | NULL | Recruiting | 14 Years | 75 Years | Both | 180 | Phase 2 | China |
| 7 | 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 |
| 8 | NCT01282073 (ClinicalTrials.gov) | March 2011 | 19/1/2011 | Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy | A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy | Glomerulonephritis, Membranous | Drug: Mycophenolate mofetil, low dose steroid;Drug: Cyclosporin, low dose steroid | Kyungpook National University | Hanmi Pharmaceutical Company Limited | Recruiting | 18 Years | N/A | Both | 62 | Phase 3 | Korea, Republic of |
| 9 | 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 |
| 10 | JPRN-UMIN000001099 | 2007/10/01 | 31/03/2008 | Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome | Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome - Optimal use of ciclosporin in membranous nephropathy (OCIM-NS study) | idiopathic membranous nephropathy associated with nephrotic syndrome | Steroid group: Immunosuppressive therapy is started by predonisolone 0.8mg/kg/day (max 60mg/day). The dose is decreased by 5mg/day in 2 to 4 weeks after remission. The cases who do not reach remission for 4 weeks, predonisolone is decreased to 0.6mg/kg/day, and ciclosporin (2mg/kg/day) is started once a day. Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.) Steroid + ciclosporin group: Immunosupressive therapy is started by predonisolone 0.6mg/kg/day and ciclosporin 2mg/kg/day (once a day). Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.) The dose of predonisolone is decreased by 5mg/day in 2 to 4 weeks after remission. Ciclosporin is continued after remission. (The target C2 is 600-800 ng/mL.) The cases who do not reach remission after 4 weeks, predonisolone is decreased by 5mg/4-8week, and ciclosporin is continued for 6 months. The target C2 is 800-1000ng/mL. At 6 months after, the therapy of non-respnder is not restricted. | Division of Kidney and Dialysis, Department of Internal Medicine,Hyogo College of Medicine | NULL | 16years-old | Not applicable | Male and Female | 50 | Phase 4 | Japan | |
| 11 | JPRN-UMIN000000963 | 2007/10/01 | 01/01/2010 | Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome | Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome - Cyclosporine for MCNS | Minimal change nephrotic syndrome | administration of cyclosporine | Yoshihiko Saito | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 30 | Not applicable | Japan |
| 12 | JPRN-UMIN000000621 | 2007/03/01 | 28/02/2007 | Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission | Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission - ONTRACK | Minimal change nephrotic syndrome | Prednisolone (+), combination therapy (-) Prednisolone (+), combination therapy (+) | Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 13 | JPRN-UMIN000004653 | 2005/01/01 | 02/12/2010 | The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS | The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS - The effects of cyclosporine in onset MCNS | minimal change nephrotic syndrome | cyclosporine A 2-3mg/kg/day | Yokohama city university graduate school of medicine | NULL | Complete: follow-up continuing | 16years-old | Not applicable | Male and Female | 20 | Not applicable | Japan |
| 14 | NCT00135811 (ClinicalTrials.gov) | November 2004 | 24/8/2005 | Focal Segmental Glomerulosclerosis Clinical Trial (FSGS-CT) | Focal Segmental Glomerulosclerosis Clinical Trial | Glomerulosclerosis, Focal | Drug: Cyclosporin;Drug: MMF and Dexamethasone | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | The Cleveland Clinic | Completed | 2 Years | 40 Years | Both | 207 | Phase 3 | United States |
| 15 | JPRN-C000000369 | 2004/04/01 | 27/03/2006 | Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome | Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome - Combine therapy of prednisolone and cyclosporin in refractory nephrotic syndrome | membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome | CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks | Project team for treatment of refractory nephrotic syndrome | The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 300 | Not selected | Japan |