Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Patient Survival
研究概览
简要总结
After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood.
The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.
详细描述
Special attention will be paid to the epidemiology of virus infections behind one year post transplant. Very limited data are available on this issue and there is suspicion that tacrolimus patients suffer more hard with viruses like CMV, EBV, BKV. These viruses can induce graft nephropathy and threat to the life of the recipient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first kidney allograft recipients
- •alemtuzumab induction
排除标准
- •CNI intolerance
研究组 & 干预措施
cyclosporine group
cyclosporine group - after alemtuzumab induction cyclosporine was administered
干预措施: cyclosporine or tacrolimus (Drug)
tacrolimus group
tacrolimus group - after alemtuzumab induction tacrolimus was administered
干预措施: cyclosporine or tacrolimus (Drug)
结局指标
主要结局
Patient Survival
时间窗: 5 years
in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Graft Survival
时间窗: 5 years
in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%
次要结局
未报告次要终点
研究者
Michael Kaabak
professor
Russian Academy of Medical Sciences