NCT01159080已完成4 期
Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study
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
- 350
- 试验地点
- 1
- 主要终点
- estimated GFR (MDRD equation)12 months after randomization
研究概览
简要总结
To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects
Primary endpoints:
- estimated GFR (MDRD equation) 12 months after randomization
- estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
routine dose tacrolimus and less myfortic
Active Comparator
干预措施: routine dose tacrolimus and less myfortic (Drug)
reduced dose tacrolimus and conventional myfortic
Experimental
干预措施: reduced dose tacrolimus and conventional myfortic (Drug)
结局指标
主要结局
estimated GFR (MDRD equation)12 months after randomization
时间窗: 12 months after randomization
次要结局
- Urine protein excretion(12 months after randomization)
- graft survival(12 month after randomization)
- follow-up loss(From randomization to 12 months after randomization)
- Treated or biopsy proven acute rejection(From randomization to 12 months after randomization)
- Allograft biopsy(From randomization to 12 months after randomization)
- estimated GFR change from randomization to end of the study(12 months after randomization)
研究者
Su-Kil Park
Professor, Department of medicine, ASAN Medical CENTER
Asan Medical Center
研究点 (1)
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