NCT00403416已完成1 期
12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 28
- 主要终点
- Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up
研究概览
简要总结
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mycophenolic Acid / tacrolimus
Active Comparator
干预措施: Mycophenolic Acid (Drug)
AEB071 / tacrolimus arm 1
Experimental
干预措施: AEB071 (Drug)
AEB071 / tacrolimus arm 2
Experimental
干预措施: AEB071 (Drug)
结局指标
主要结局
Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up
时间窗: at 6 months
次要结局
- Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)(at 6 months)
- Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up(at 3 and 12 months)
- Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.(at Month 3, 6 and 12)
- Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms(from Month 3 to Month 6)
- Safety and tolerability(at 3, 6 and 12 months)
研究者
研究点 (28)
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