NCT00189839已完成3 期
A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 699
- 主要终点
- Time to and incidence of biopsy-proven acute rejections
研究概览
简要总结
The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.
详细描述
A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type.
- •Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).
排除标准
- •Patients receiving or having previously received an organ transplant other than a kidney.
- •Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade >50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons.
- •Cold ischaemia time of the donor kidney >30 hours.
研究组 & 干预措施
1
Active Comparator
干预措施: tacrolimus (Drug)
2
Experimental
干预措施: tacrolimus (Drug)
结局指标
主要结局
Time to and incidence of biopsy-proven acute rejections
时间窗: 12 months
次要结局
- Overall rate of acute rejections(12 months)
研究者
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