A Comparative, Open-label Study to Evaluate Graft Function in de Novo Renal Allograft Recipients Treated With Either a 'Reduced Dose' or a 'Standard Dose' of Cyclosporine in Combination With Sirolimus and Corticosteroids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 主要终点
- Calculated creatinine clearance to evaluate renal function at 12 months post transplantation
研究概览
简要总结
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.
详细描述
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.
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 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults more than 18 years of age
- •End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor
- •Patients with a secondary transplant must have maintained their primary graft for at least 6 months
排除标准
- •Planned antibody induction therapy
- •Multiple organ transplants
- •Patients at a high risk of acute rejection
结局指标
主要结局
Calculated creatinine clearance to evaluate renal function at 12 months post transplantation
时间窗: 12 months
次要结局
- Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation(12 months)