A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 212
- 主要终点
- Time to first BPAR episode or treatment failure
研究概览
简要总结
The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are recipients of primary or secondary renal allograft.
- •Patients who are single-organ recipients (kidney only).
排除标准
- •Patients who are recipients of HLA-identical renal transplants. Patients whose donor kidney cold ischemia time (CIT) is greater than 36 hours. Patients whose transplant kidney is obtained from a non-heart beating donor Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Basiliximab
Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids
干预措施: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent) (Drug)
Basiliximab-free
Patients will be on a regimen of MMF, cyclosporine and steroids.
干预措施: MMF, cyclosporine, steroids (Drug)
结局指标
主要结局
Time to first BPAR episode or treatment failure
时间窗: 6 months
Treatment failure is defined as: graft loss, death, or initiation of anti-rejection therapy without prior biopsy-proven rejection (in case of medical contraindication for a biopsy).
次要结局
未报告次要终点