NCT01203709已完成4 期
Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical remission rate
研究概览
简要总结
A trial of combination of two drugs for the treatment of refractory lupus nephritis.
详细描述
Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active nephritis documented by renal biopsy within 24 months of entry;
- •Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
- •Serum creatinine (Scr) less than 200umol/L.
排除标准
- •Previous intolerance to either MMF/Tac;
- •Scr >200umol/L;
- •Informed consent unavailable.
研究组 & 干预措施
Combination treatment
Experimental
treatment arm
干预措施: low dose combination of MMF and Tac (Drug)
结局指标
主要结局
Clinical remission rate
时间窗: 12 months
次要结局
- Adverse events(12 months)
研究者
Chi Chiu Mok
Consultant
Tuen Mun Hospital
研究点 (1)
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