NCT00282230终止2 期
A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Prograf®/FK778 and Prograf®/MMF in De Novo Kidney Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 23
- 主要终点
- Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
研究概览
简要总结
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
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
- •Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
- •Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.
排除标准
- •Patient has received or is receiving an organ transplant other than kidney
- •Patient has received a kidney transplant from a cadaveric donor >= 60 years of age.
结局指标
主要结局
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
次要结局
- 6 month patient and graft survival rates
- time to first biopsy confirmed acute rejection
- clinically treated acute rejection episodes
- treatment failure (up to 6 months)
- renal function (SrCl and CrCl)
- quantitation of CMV and polyomavirus viral load
研究者
研究点 (23)
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