A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- - Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
研究概览
简要总结
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 and < 65 years
- •End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
- •Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant
排除标准
- •Evidence of active systemic or localized major infection at the time of initial sirolimus administration
- •Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
- •Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase
结局指标
主要结局
- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
transplantation.
次要结局
- Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
- criteria at 3, 6 and 12 Months following transplantation
- One year graft biopsy status
- Incidence of document infection