NCT01269021已完成不适用
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Zhi-Hong Liu, M.D.1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- the rate of complete remission (CR) at 6 months
研究概览
简要总结
In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open, prospective, randomized parallel study to access the efficacy and safety of MMF compared to corticosteroid .
Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the MMF group or corticosteroid group.
详细描述
To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed written informed consent form
- •age between 18-60 years, female or male
- •diagnosed IgA Nephropathy (IgAN) by renal biopsy during 1 months
- •renal biopsy had: 10%< crescents<50%; endocapillary hypercellularity; or necrosis ,and interstitial fibrosis<50%,
- •proteinuria>1g/24h for two times
排除标准
- •secondary IgA Nephropathy (IgAN);
- •eGFR<30ml/min/1.73m2.( MDRD formula)
- •liver disfunction;
- •uncontrolled hypertension
- •WBC <3000/mm3
- •Severe viral infection(HBV, HCV, CMV) within 3 months ofor known HIV infection.
- •diabetes or obesity(BMI>28) ;
- •severe infection or central nervous system symptoms.
研究组 & 干预措施
mycophenolate mofetil
Experimental
干预措施: mycophenolate mofetil plus lower dose of Prednisone (Drug)
Prednisone
Active Comparator
干预措施: Prednisone in full dose (Drug)
结局指标
主要结局
the rate of complete remission (CR) at 6 months
时间窗: 6 months
次要结局
- the relapse rate after stopping the treatments(12 months)
- the median time to CR(from the start of enrollment to the day of complete remission)
- the rate of overall response (CR+ partial remission [PR]) at 6 months(6 months)
研究者
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
研究点 (1)
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