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To demonstrate that the treatment effect in lupus nephritis 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 | |||
| China-Japan Friendship Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40085084 | Derived | Dong Z, Luo P, Sun S, Ni Z, He Y, Huang X, Liu Z, Wu Z, Zhang X, Liao Y, Zhao J, Lin H, Zhang X, Fu R, Ding G, Xu Y, Wang L, Xiao Y, Shi S, Zuo X, Li Z, Qiao L, Wang R, Li W, Wan J, Li Y, Guan T, Deng X, Wu X, Zheng H, Chen J, He L, Yamaguchi S, Wang H, Cai GY, Zhang L, Chen X. Mizoribine or Cyclophosphamide for Lupus Nephritis: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250648. doi: 10.1001/jamanetworkopen.2025.0648. |
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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 |
| Changes of immunological test (C3, Anti-DNA antibody, ANA, Anti-Sm antibody and Anti-phospholipid antibody) from baseline | 20 weeks and 52 weeks |
| Changes of SLE-DAI score from baseline | 20 weeks and 52 weeks |
| Progression to End-Stage Renal Disease or Doubling of SCr through the study. | 52 weeks |
| Beijing |
| Beijing Municipality |
| China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
| The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital) | Chongqing | Chongqing Municipality | China |
| The first Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 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 |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China |
| Wuxi People's Hospital | Wuxi | Jiangsu | 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 |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| The First Affiliated Hospital of the Fourth Military Medical University (Xijing Hospital) | 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 |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System 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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