A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis
- Conditions
- Lupus Nephritis
- Interventions
- Registration Number
- NCT02256150
- Lead Sponsor
- Asahi Kasei Pharma Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Patient has been diagnosed with SLE according to American College of Rheumatology (ACR) criteria in 1997;
- Patient who has had a kidney biopsy within 365 days prior to screening which was confirmed as class III, III+V, IV, IV+V, or V according to the pathologic classification of International Society of Nephrology/Renal Pathology Society (ISN/RPS) in 2003;
- Patient with 24hr-urine protein β₯ 1.0g;
- SLE-DAI > 8 ;
- Male or female patient between 18 and 70 years (inclusive) at informed consent obtained date;
- Patient with body weight between 40kg and 80kg (inclusive) at screening;
- Patients who sign the informed consent form;
- Patient who had history of allergy to any investigational product (MZR, CTX) or hormone;
- Patient who had received accumulated dosage of CTX >3g within one year prior to screening.
- Patient who had received immunosuppressant or Chinese traditional medicine with immunosuppressive effect within 30 days prior to screening;
- Patient who had received prednisone>1.0mg/kg/day or equivalent dose of other oral glucocorticoid therapies within 30 days prior to screening;
- Patient who received other investigational drugs within 30 days prior to screening;
- Patient who have received plasma exchange therapy or immunoadsorption therapy within 30 days prior to screening;
- Patient who require pentostatin or live vaccine (not including flu vaccine);
- Patient who is undergoing renal replacement therapy;
- Patient who received kidney transplantation;
- Patient with malignancy;
- Patient with severe hypertension (SBP > 160mmHg or DBP > 100mmHg) which has not been effectively controlled;
- Patient with white blood cell count <3Γ109/L /L(=3.0 GI/L);
- Patient with SCr > 176.8ΞΌmol/L;
- Patient who has a value that is > 3 times of the upper limit of normal range for AST or ALT;
- Patient with hepatitis B, hepatitis C or HIV infection;
- Patient with other serious infections;
- Patient who is unsuitable for participating in this study in the opinion of investigators ( e.g. uncontrolled diabetes, central nervous system lupus , lupus encephalopathy, active psychosis,osteonecrosis of the femoral head, fulminant hepatitis, peptic ulcer, etc.);
- Female patient who is pregnant, currently breast feeding or willing to become pregnant;
- Patient with any other diseases that would affect the evaluation of efficacy or safety.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mizoribine (MZR) Mizoribine (MZR) Oral administration, daily dose of 150mg (50mg/tablet, t.i.d) All study subjects will receive standard steroid therapies during the study. Cyclophosphamide (CTX) Cyclophosphamide (CTX) 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.
- Primary Outcome Measures
Name Time Method Total Remission rate 52 weeks
- Secondary Outcome Measures
Name Time Method Changes of Overall Remission rate 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks Complete Remission rate 52 weeks Partial Remission rate 52 weeks Changes of SLE-DAI score from baseline 20 weeks and 52 weeks Changes of Complete Remission rate 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks Treatment failure rate 52 weeks Changes of partial remission rate 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 Changes of immunological test (C3, Anti-DNA antibody, ANA, Anti-Sm antibody and Anti-phospholipid antibody) from baseline 20 weeks and 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
Trial Locations
- Locations (26)
The first Affiliated Hospital of Fujian Medical University
π¨π³Fuzhou, Fujian, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
π¨π³Wuhan, Hubei, China
The First Affiliated Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
Wuxi People's Hospital
π¨π³Wuxi, Jiangsu, China
Shandong Provincial Hospital
π¨π³Jinan, Shandong, China
The First Affiliated Hospital of the Fourth Military Medical University (Xijing Hospital)
π¨π³Xian, Shanxi, China
The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital)
π¨π³Chongqing, Chongqing, China
Affiliated Hospital of Guilin Medical University
π¨π³Guilin, Guangxi, China
Beijing Friendship Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
Peking University People's Hospital
π¨π³Beijing, Beijing, China
Renmin Hospital of Wuhan University
π¨π³Wuhan, Hubei, China
The General Hospital of Shenyang Military Region
π¨π³Shenyang, Liaoning, China
Chinese PLA General Hospital
π¨π³Beijing, Beijing, China
The Second Hospital of Jilin University
π¨π³Changchun, Jilin, China
The Affilited Hospital of Qingdao University
π¨π³Qingdao, Shandong, China
Zhongshan Hospital Fudan University
π¨π³Shanghai, Shanghai, China
The General Hospital of Jinan Military Region
π¨π³Jinan, Shandong, China
Renji Hospital Shanghai Jiaotong University School of Medical
π¨π³Shanghai, Shanghai, China
Kuming General Hospital of Chengdu Military Region
π¨π³Kunming, Yunnan, China
West China Hospital of Sichuan University
π¨π³Chengdu, Sichuan, China
The Third Hospital of Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
China-Japan Friendship Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
The Second Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
π¨π³Hangzhou, Zhejiang, China