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To demonstrate that the treatment effect in refractory nephrotic syndrome of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mizoribine (MZR) | Experimental | Oral administration, daily dose of 150mg (50mg/tablet, t.i.d) All study subjects will receive standard steroid therapies during the study. |
|
| Cyclophosphamide (CTX) | Active Comparator | Intravenous injection with between 0.5 to 1.0 g/m2 body surface area each time (the maximum dose is 1.0 g/day each time). All study subjects will receive standard steroid therapies during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mizoribine (MZR) | Drug |
|
| |
| Cyclophosphamide (CTX) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Remission rate | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission rate | 52 weeks | |
| Partial Remission rate | 52 weeks | |
| Changes of Overall Remission rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asahi Kasei Pharma Corporation | Asahi Kasei Therapeutics Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Beijing Tongren Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36990111 | Derived | Dong Z, Zhou J, Xu Z, Ni Z, He Y, Lin H, Jiang G, Sun X, Zhang L, Chen X. Efficacy and Safety of Mizoribine for the Treatment of Refractory Nephrotic Syndrome: Protocol for a Multicenter, Controlled, Open-label, Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 16;12:e46101. doi: 10.2196/46101. |
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| Drug |
|
| 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Changes of Complete Remission rate | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Changes of Partial Remission rate | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Treatment failure rate | 52 weeks |
| Changes and percentage change of 24 hours urine protein and serum albumin from the baseline | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Changes of and percentage change of SCr, eGFR and BUN from the baseline | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Progression to End-Stage Renal Disease or Doubling of SCr through the study | 52 weeks |
| Beijing |
| Beijing Municipality |
| China |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
| The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital) | Chongqing | Chongqing Municipality | China |
| Fuzhou General Hospital of Nanjing Military Region | Fuzhou | Fujian | China |
| The first Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Wuxi People's Hospital | Wuxi | Jiangsu | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| The Second Hospital of Jilin University | Changchun | Jilin | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
| The General Hospital of Shenyang Military Region | Shenyang | Liaoning | China |
| Shandong Provincial Hospital | Jinan | Shandong | China |
| The General Hospital of Jinan Military Region | Jinan | Shandong | China |
| The Affilited Hospital of Qingdao University | Qingdao | Shandong | China |
| Renji Hospital Shanghai Jiaotong University School of Medical | Shanghai | Shanghai Municipality | China |
| Xinhua Hospital Shanghai Jiaotong University School of Medical | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xian | Shanxi | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Kuming General Hospital of Chengdu Military Region | Kunming | Yunnan | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C010052 | mizoribine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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