NCT00885547终止不适用
Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.
Nanjing University School of Medicine0 个研究点目标入组 90 人开始时间: 2009年3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
- 终止
- 发起方
- 入组人数
- 90
- 主要终点
- The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.
研究概览
简要总结
The purpose of this study is to:
- To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis.
- To evaluate the safety and tolerability of TW.
详细描述
Patients who fit the inclusion criteria will be randomly divided into three groups: TW group (TW at dosage of 90 mg/d), ARB group (the control group, valsartan at dosage of 160 mg/d) and combined treatment group (TW at dosage of 60 mg/d and valsartan at dosage of 80 mg/d).
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
- •18-60 years old but no requirement for gender
- •All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis
- •Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement
排除标准
- •Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on
- •Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis
- •Severe infection
- •Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal
- •Women during pregnancy and lactation
- •Patients need to procreation lately
- •Patients treated with TW or ARB within 4 months
研究组 & 干预措施
immunosuppressor
Experimental
干预措施: tripterygium wilfordii (TW) (Drug)
结局指标
主要结局
The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.
时间窗: 12 months
次要结局
- The percentage of total effect of the 3 groups and adverse event within the follow-up periods.(12 months)
研究者
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
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