NCT00518219已完成4 期
To Compare the Efficacy and Safety of TW vs Valsartan in the MN
Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy
研究概览
简要总结
The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.
详细描述
Membranous nephropathy with heavy proteinuria have high risks of progressing to CRF.
Tripterygium (TW) is a Chinese traditional patent drugs, it can reduce proteinuria of chronic glomerular nephritis,such as IgA nephropathy. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus Valsartan in the treatment of heavy proteinuria of MN.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven idiopathic membranous nephropathy
- •Nephrotic syndrome with proteinuria (> 4 g/day) and serum albumin < 30 g/dl
- •Age over 18 with informed consent
排除标准
- •Patient with abnormal liver function tests
- •Prior therapy with sirolimus, CSA, MMF, tacrolimus or azathioprin, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days,
- •Active/serious infection,
- •Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
研究组 & 干预措施
immunosuppressor
Experimental
TW 120mg/d，Valsartan,160mg/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 membranous nephropathy
时间窗: 12 months
次要结局
- To investigate the safety and tolerability of TW vs ARB in treatment of MN(12 months)
研究者
研究点 (1)
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