Mizoribine (DrugBank: Mizoribine)
8 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 2 |
| 49 | 全身性エリテマトーデス | 2 |
| 51 | 全身性強皮症 | 1 |
| 53 | シェーグレン症候群 | 1 |
| 66 | IgA腎症 | 6 |
| 94 | 原発性硬化性胆管炎 | 2 |
| 222 | 一次性ネフローゼ症候群 | 5 |
| 224 | 紫斑病性腎炎 | 1 |
| 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 | NCT02373202 (ClinicalTrials.gov) | February 2015 | 12/2/2015 | A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) | A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine | Sanofi | Regeneron Pharmaceuticals | Completed | 20 Years | N/A | All | 91 | Phase 3 | Japan |
| 2 | NCT02005757 (ClinicalTrials.gov) | November 2013 | 4/12/2013 | Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED) | Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug | Rheumatoid Arthritis | Drug: Bredinin tablet 150mg;Drug: Bredinin tablet 50mg | Chong Kun Dang Pharmaceutical | NULL | Recruiting | 20 Years | 80 Years | Both | 60 | Phase 2 | Korea, Republic of |
| 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 | JPRN-C000000159 | 2006/03/01 | 01/04/2006 | Mizolibin for systemic lupus erythematosus in children(JSRDC10) | systematic lupus erythematosus | Methylprednisolone+mizoribine+prednisolone | Japanese Study Group of Renal Disease in Children(JSRDC) | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 30 | Not selected | Japan | |
| 2 | JPRN-C000000378 | 1995/03/01 | 01/04/2006 | A combination of methylprednisoloneand prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04) | systematic lupus erythematosus | Methylprednisolone+prednisolone Methylprednisolone+prednisolone+mizoribine | Japanese Study Group of Renal Disease in Children(JSRDC) | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 60 | Not selected | Japan |
| 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 | JPRN-UMIN000004162 | 2010/09/01 | 05/09/2010 | The efficacy of Mizoribine for scleroderma of systemic sclerosis. | systemic sclerosis | a group of Mizoribine a group of the existing treatment | Faculty of Life Sciences, Kumamoto University | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan |
| 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 | JPRN-UMIN000004237 | 2013/03/31 | 19/09/2010 | Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age | Sjogren's syndrome in pediatric age | Mizoribine 10 mg/kg (up to 500 mg) will be administered once daily twice a week. | Graduate School of Medicine, Chiba University | NULL | Complete: follow-up complete | 10years-old | 20years-old | Male and Female | 5 | Phase 2 | Japan |
| 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 | ChiCTR-TRC-13003038 | 2013-01-01 | 2013-01-11 | Mizoribine for the Treatment of Pediatric IgA Nephropathy | Mizoribine for the Treatment of Pediatric IgA Nephropathy with Moderate Proteinuria--An open, prospective, random, multicenter study | IgA nephropathy | MZR:mizoribine tablet 4 mg/kg a day (not more than 150 mg/d), qd, po + Dipyridamole, 3 mg/kg a day (not more than 25 mg at a time), tid, po;CVT:Lotensin, 0.2 mg/kg a day (not more than 10 mg/d), qd, po + + Dipyridamole, 3 mg/kg a day (not more than 25 mg at a time), tid, po; | Peking University First Hospital | NULL | Completed | 6 | 18 | Both | MZR:60;CVT:60; | China | |
| 2 | ChiCTR-ONC-10001124 | 2011-01-01 | 2010-12-04 | The effect and safety of mizoribine for IgA Nephropathy in children | The effect and safety of mizoribine for IgA Nephropathy in children | IgA nephropathy | 1:mizoribine 3~5mg/kg.d; | Nanjing general hospital of Nanjing military command | NULL | Completed | 5 | 16 | Both | 1:30; | China | |
| 3 | JPRN-UMIN000000593 | 2006/11/01 | 05/02/2007 | Randomized controlled trial of mizoribine for progressive IgA nephropathy | IgA nephropathy with moderate to severe histological alterations | Methylprednisolone pulse therapy followed by oral prednisolone administration Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration | West Japan Study Group for Therapy of IgA Nephropathy | NULL | Complete: follow-up complete | 15years-old | 60years-old | Male and Female | 120 | Not selected | Japan | |
| 4 | JPRN-C000000341 | 2004/04/01 | 31/03/2006 | Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy | Refractory IgA nephropathy | Prednisolone and anti-thrombocyte and angiotensin II receptor blocker or angiotensin converting enzyme inhibitor inhibitor mizoribine and Prednisolone and anti thrombocyte and angiotensin II receptor blocker or angiotensin-converting enzyme | Japanese Study Group of Multiple drug therapy for IgAN | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 60 | Not selected | Japan | |
| 5 | JPRN-C000000363 | 2001/08/01 | 14/05/2007 | A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial prolideration in children:A randomized controlled trial of efficacy and safety | IgA nephropathy in children | prednisolone+mizoribine for 2 years prednisolone+mizoribine+warfarin+dipyridamole for 2 years | The Japanese Pediatric IgA Nephropathy ofTreatment Study Group | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 80 | Not selected | Japan | |
| 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 |
| 6 | JPRN-C000000375 | 1998/08/01 | 01/04/2006 | A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children. | IgA nephropathy in children | prednisolone+mizoribine+warfarin+dipyridamole for 2 years | The Japanese Pediatric IgA Nephropathy of Treatment Study Group | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 20 | Not selected | Japan |
| 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 | JPRN-jRCTs051180120 | 01/04/2012 | 13/03/2019 | Examination of the mizoribine and azathioprine combination immunosuppressive therapy in primary sclerosing cholangitis | Examination of the immunosuppressive drug combination therapy in primary sclerosing cholangitisStudy of the mizoribine and azathioprine combination immunosuppressive therapy - Examination of the immunosuppressive drug combination therapy in primary sclerosing cholangitis | Primary sclerosing cholangitis; PSC;K830 | 1 MZR Daily intake of mizoribine once before breakfast. Dose adjustment is done to achieve a blood concentration level over 3.0 microg/ml at 3 hour after meal. 2)AZT Daily intake of azathioprine once after breakfast and once after dinner. Starting dose is 0.5-1.0mg/kg daily (max 2.0mg) , is increased according to the condition of patients. Dose is adjusted to achieve WBC 3000-5000/m3, neutrophils 2000-3500/m3(the dose of 6MP is appotoimatery half of azathioprine). Continue the dosage during a study period. | Tajiri Hitoshi | NULL | Recruiting | 3age | 18age | Both | 10 | Phase 2 | Japan |
| 2 | JPRN-UMIN000029482 | 2012/04/01 | 10/10/2017 | Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine - | Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine - - Study of combination immunosuppressive therapy in primary sclerosing cholangitis | Primary sclerosing cholangitis | Administration of mizoribine and azathioprine | Osaka General Medical Center | NULL | Complete: follow-up continuing | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan |
| 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 | ChiCTR-IPR-17011702 | 2017-07-01 | 2017-06-19 | Compare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroid | Compare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroid | membranous nephropathy | mizoribine group:treated with mizoribine and steroid;cyclophosphamide group:treated with cyclophosphamide and steroid; | Tianjin First Central Hospital | NULL | Pending | 18 | 65 | Both | mizoribine group:50;cyclophosphamide group:50; | China | |
| 2 | JPRN-UMIN000008919 | 2012/09/15 | 14/09/2012 | The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy. | The patients with nephrotic syndrome due to primary membranous nephropathy. | Treatment with a combination of mizoribine plus steroid therapy Treatment with steroid monotherapy | The study group of treatment for aged patients with nephrotic syndrome. | NULL | Complete: follow-up complete | 65years-old | Not applicable | Male and Female | 200 | Not applicable | Japan | |
| 3 | JPRN-C000000158 | 2006/03/01 | 01/04/2006 | Mizoribin for primary nephrotic syndrome in children(JSRDC09) | Steroid-sensitive nephrotic syndrome | mizoribine+prednisolone | Japanese Study Group of Renal Disease in Children(JSRDC) | NULL | Complete: follow-up complete | 1years-old | 10years-old | Male and Female | 50 | Not selected | Japan | |
| 4 | JPRN-C000000368 | 2004/04/01 | 27/03/2006 | Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome | membranous nephropathy with primary steroid resistant nephrotic syndrome | mizoribine once a day per os administration (150mg) after breakfast for 2years. mizoribine 3 times a day per os administration (50mg each) after meals for 2years. | 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 | 100 | Not selected | Japan | |
| 5 | JPRN-C000000379 | 2001/04/01 | 01/04/2006 | Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06) | Steroid-sensitive nephrotic syndrome | prednisolone mizoribine+prednisolone | Japanese Study Group of Renal Disease in Children(JSRDC) | NULL | Complete: follow-up complete | 1years-old | 10years-old | Male and Female | 50 | Not selected | Japan |
| 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 | ChiCTR-IPC-16008619 | 2016-07-01 | 2016-06-09 | Efficacy of Mizoribine for Children with Henoch-Schnlein Purpura Nephritis Presenting with Nephrotic Range Proteinuria: A Prospective and Controlled Study in China | Efficacy of Mizoribine for Children with Henoch-Schnlein Purpura Nephritis Presenting with Nephrotic Range Proteinuria: A Prospective and Controlled Study in China | Children with Henoch-Sch?nlein Purpura Nephritis | mizoribine:5 mg/kg body weight daily (maximum total dose: 150 mg); | Nanjing General Hospital of Nanjing Military Command | NULL | Pending | 5 | 18 | Both | mizoribine:180; | China |