A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination of Tacrolimus and Mycophenolate Mofetil Based Regimen With or Without Induction in Elderly Recipients Undergoing Kidney Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 主要终点
- Renal function measured by creatinine clearance
研究概览
简要总结
Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.
详细描述
The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortality and graft loss rates than classic cyclosporin protocols. Nevertheless, the efficacy and safety of tacrolimus in monotherapy, double or triple therapy with MMF, as well as the induction therapy with the new anti-IL2 receptor antibodies have not been adequately used in controlled trials in the elderly renal transplant patient. There is only scarce information on age-associated immune responsiveness and only a few aged-adapted immunosuppressive regimens have been described.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with minimum 60 years of age and end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.
排除标准
- •Patient has an immunological high risk
- •Cold ischemia time greater than 30 hours.
- •Patient has significant liver disease
- •Patient is allergic or intolerant to study medication
- •Patient or donor is known to be HIV positive.
- •Patient with malignancy or history of malignancy
- •Patient has significant, uncontrolled concomitant infections
研究组 & 干预措施
2
干预措施: Tacrolimus (Drug)
1
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Renal function measured by creatinine clearance
时间窗: 6 months
次要结局
- Acute rejection(6 months)