NCT00820911已完成2 期
An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula
研究概览
简要总结
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
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 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
cyclosporine (reduced exposure) / everolimus
Active Comparator
干预措施: cyclosporine (reduced exposure) / everolimus (Drug)
AEB071 300 mg b.i.d. / everolimus
Experimental
干预措施: AEB071 300 mg b.i.d. / everolimus (Drug)
AEB071 200 mg b.i.d. / everolimus
Experimental
干预措施: AEB071 200 mg b.i.d. / everolimus (Drug)
结局指标
主要结局
renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula
时间窗: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
次要结局
- efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up(at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation)
研究者
研究点 (1)
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