NCT02257697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 Refractory Nephrotic Syndrome
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
- 239
- 试验地点
- 28
- 主要终点
- Total Remission rate
研究概览
简要总结
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.
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
- •Patients who have medical history with clear documentation of diagnosis of nephrotic syndrome
- •Patient who received renal biopsy within 1 year prior to screening and confirmed the pathologic classification: Minimal Change Disease (MCD), IgA nephropathy, Mesangioproliferative Glomerulonephritis (MsPGN), Membranous Nephropathy (MN), Focal Segmental Glomerulosclerosis (FSGS)
- •Patient with the above different pathologic classification who received adequate hormone therapy more than 8 weeks (including FSGS more than 12 weeks)prior to screening and have 24hr-urine protein≥2.0g/day at screening Adequate hormone dose is defined as prednisone (prednisolone) equivalent dose of 0.8 to 1.0 mg/kg/day (inclusive)
- •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
- •Other primary nephrotic syndrome, e.g. membrano-proliferative glomerulonephritis (MPGN)
- •Secondary nephrotic syndrome (e.g. diabetic nephropathy, anaphylactic purpura nephritis, lupus nephritis, type B hepatitis-related nephritis, renal amyloidosis)
- •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 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 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)
研究者
研究点 (28)
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