NCT00935389已完成不适用
Prospective Control Study of TW in the Treatment of LN Type V With Gross Proteinuria
Nanjing University School of Medicine2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2009年4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
- 44
- 试验地点
- 2
- 主要终点
- To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
研究概览
简要总结
The purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.
详细描述
Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
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
- •SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.
- •Urine protein≥3.0g/24h, Alb<30g/L and Scr<1.5mg/dL.
- •All cases are type IV, confirmed by renal biopsy.
- •All patients sign the informed consent and be willing to follow-up on time
排除标准
- •Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.
- •Scr level above 1.5mg/dL, lasts more than 3 months.
- •Heart, lung or central nervous systems involved or combined with severe infection.
- •With liver function abnormal, ALT or AST being two times above the normal.
- •Pregnant women or patients still in lactation.
研究组 & 干预措施
immunosuppressor
Experimental
TW 30mg,q.d.*3 months and reduced into 20mg b.i.d
干预措施: tripterygium glycosides (Drug)
结局指标
主要结局
To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
时间窗: 48 months
次要结局
未报告次要终点
研究者
研究点 (2)
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