NCT00504543已完成2 期
A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, 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
- 311
- 试验地点
- 12
- 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, 3 months after transplantation.
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 —（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
Neoral
Active Comparator
干预措施: Neoral (Drug)
AEB071 high dose with Cetican reduced dose
Active Comparator
干预措施: AEB071 (Drug)
AEB071 high dose with Cetican reduced dose
Active Comparator
干预措施: Certican (Drug)
AEB071 low dose with Cetican standard dose
Active Comparator
干预措施: AEB071 (Drug)
AEB071 low dose with Cetican standard dose
Active Comparator
干预措施: Certican (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, 3 months after transplantation.
时间窗: 12 months
次要结局
- Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK(12 months)
研究者
研究点 (12)
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