To Compare the Efficacy and Safety of Tripterygium (TW) Versus Valsartan in the Diabetic Nephropathy (DN)
To Compare the Efficacy and Safety of TW vs Valsartan in the DN
研究概览
详细说明
Diabetic nephropathy with heavy proteinuria have high risks of progressing to end stage renal disease. Though recent studies have shown that ACEI or ARB could reduce proteinuria of DN and slowed the progression to ESRD. But ARBs can only reduce proteinuria about 30%, so some patients still have heavy proteinuria,and then loss their renal function rapidly. So, to reduce the proteinuria of DN is a very important therapy target.
Tripterygium (TW) is a Chinese traditional patent drug, it can reduce proteinuria of chronic glomerular nephritis. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus ARB in the treatment of heavy proteinuria of DN.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Jiangsu
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Nanjing、Jiangsu、中国、210002
- Research Institute of Nephrology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
- Proteinuria > 2.5 g/24 h
- serum creatinine < 3 mg/dl
- age 35-65 years
Exclusion Criteria:
- Co-existence of anther chronic glomerular nephritis.
- Severe disfunction of the liver
- White blood cell < 3000/ul
- Severe infection in the past 1 month
- Malignant hypertension which in hard to control
- Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：immunosuppressor
Valsartan,160mg/d,TW 120mg/d
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TW,120 mg/d
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy
大体时间：6 months
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6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To investigate the safety and tolerability of TW vs ARB. To access whether TW can delay the progression to ESRD or creatinine-doubling in diabetic nephropathy with heavy proteinuria.
大体时间：6 months
|
6 months
|
合作者和调查者
调查人员
- 首席研究员：Zhihong Liu, Master、Jinling Hospital, China
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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