NCT00518271已完成2 期
A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 120 人开始时间: 2000年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.
研究概览
简要总结
This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.
详细描述
This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.
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
- •At least 18 years of age
- •End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor
- •Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months
排除标准
- •Planned antibody induction
- •Multiple organ transplants
- •Patients at high risk of acute rejection
结局指标
主要结局
Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.
次要结局
- Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy.
研究者
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