To Compare the Efficacy and Safety of TW vs Valsartan in the DN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).
详细描述
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
immunosuppressor
Valsartan,160mg/d,TW 120mg/d
干预措施: TW (Drug)
结局指标
主要结局
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy
时间窗: 6 months
次要结局
- 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.(6 months)