Effects of Cyclosporine A Pretreatment of Deceased Donor on Kidney Graft Function: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 648
- 试验地点
- 2
- 主要终点
- Percentage of delayed graft function defined by a need of at least one hemodialysis session
研究概览
简要总结
Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.
详细描述
Organ donors included in the study are randomized to a control group receiving a placebo or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. In the operating theater organs are harvested. Thereafter, harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. The management of transplanted patients is performed as usual. According to the pretreatment of the transplant, delayed graft function during the first week (need of at least one dialysis session) was evaluated as well as kidney function at different timepoints (slow graft function, estimated creatinine clearance on day 3 and 7, acute and chronic graft rejection), length of hospital stay and mortality during the first year after transplantation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For organ donors:
- •Male and females aged 18 to 80 years
- •Brain death
- •Inclusion criteria for organ recipients:
- •Male and females aged 18 to 80 years
- •Indication of kidney transplantation
- •Informed consent
排除标准
- •For organ donors:
- •Contra-indication for multiorgan procurement (infections, cancer, etc)
- •Preexistent chronic renal failure.
- •Refusal for organ procurement by the donor (confirmed by the French national register or reported by the next-of-kin).
- •Exclusion criteria for organ recipients:
- •Need for a double kidney transplantation.
- •Need for a multiorgan transplantation
研究组 & 干预措施
intervention group
the intervention group receives 2.5 mg/kg of cyclosporine
干预措施: cyclosporine A (Drug)
control group
control group receives a placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of delayed graft function defined by a need of at least one hemodialysis session
时间窗: within the 7 days following renal transplantation.
次要结局
- Percentage of acute and chronic graft rejection(during the first year after transplantation)
- Mortality(during the first year after transplantation)
- Postoperative evolution of estimated creatinine clearance(at day 3 and 7)
- Percentage of slow graft function defined by a urine output < 1000 ml(at on 1 day after transplantation)
- Percentage of slow graft function defined by a decrease in plasma creatinine concentration of less than 30% or 70%(at day 3 and 7 after transplantation)
- Percentage of primary graft dysfunction(during the first year after transplantation)
- hospital length of stay(at day 1)