NCT02256150已完成3 期
A Multi-center, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Mizoribine in Comparison With Cyclophosphamide in the Treatment of Lupus Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 26
- 主要终点
- Total Remission rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥ 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;
排除标准
- •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 <3×109/L /L(=3.0 GI/L);
- •Patient with SCr > 176.8μmol/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.
研究组 & 干预措施
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.
干预措施: Mizoribine (MZR) (Drug)
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.
干预措施: Cyclophosphamide (CTX) (Drug)
结局指标
主要结局
Total Remission rate
时间窗: 52 weeks
次要结局
- Complete Remission rate(52 weeks)
- Partial Remission rate(52 weeks)
- Changes of Overall Remission rate(8 weeks, 20 weeks, 32 weeks, 44 weeks and 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)
研究者
研究点 (26)
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