NCT00371319已完成4 期
To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- remission rate
研究概览
简要总结
The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.
详细描述
Patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. Efficacy and adverse effects will be compared.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfill at least 4 of the ACR criteria for SLE
- •Age >= 18 years
- •Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
- •Serum creatinine < 200 umol/L at the time of randomization
排除标准
- •Patients who refuse to be randomized for treatment
- •Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
- •Serum creatinine >= 200 umol/L at the time of randomization
- •Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
- •Patients who are pregnant or plan for pregnancy within 12 months after randomization
研究组 & 干预措施
Tacrolimus
Active Comparator
Tacrolimus treatment
干预措施: tacrolimus (Drug)
mycophenolate mofetil
Active Comparator
mycophenolate mofetil
干预措施: mycophenolate mofetil (Drug)
结局指标
主要结局
remission rate
时间窗: month 6
次要结局
- renal function deterioration, relapse and mortality(month 60)
研究者
Chi Chiu Mok
Consultant
Tuen Mun Hospital
研究点 (1)
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