NCT00429377已完成3 期
Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 7
- 主要终点
- Change of Lupus Nephritis - Disease Activity Index total score
研究概览
简要总结
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
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
- Double
入排标准
- 年龄范围
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Steroid refractory lupus nephritis
- •more than 10mg of steroid failed to control disease activity
- •patients who failed to reduce the amount of steroid
- •patients who couldn't increase the amount of steroid due to side effects
排除标准
- •Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration
- •Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration
- •CNS( Central Nerve System) Lupus patients
- •hepatic failure patients
- •Serum creatinine ≧1.5mg/dL
结局指标
主要结局
Change of Lupus Nephritis - Disease Activity Index total score
次要结局
- proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
研究者
研究点 (7)
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