NCT00099749已完成2 期
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 10
- 主要终点
- Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
研究概览
简要总结
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •Between 18 to 65 years old
排除标准
- •Patients in need of multiple organ transplants
结局指标
主要结局
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
次要结局
- Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.
- Safety/tolerability based on adverse event reporting.
- BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
研究者
研究点 (10)
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