NCT04882254进行中（未招募）2 期
Normothermic Machine Perfusion as Additional Value to Hypothermic Machine Perfusion for Kidney Transplant Outcomes. A Single-centre, Open-label, Randomised, Controlled Trial.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of patients with immediate graft function
研究概览
简要总结
This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •kidney-only transplant
- •renal replacement therapy at time of transplant
- •receiving standard immunosuppression regimen post-transplant.
- •Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.
排除标准
- •pre-emptive at time of transplant
- •receive a multi-organ or dual kidney transplant
- •age donor or recipient below 18 years
- •Maastricht type I and II DCD
- •donor kidneys preserved on static cold storage (SCS)
- •kidneys retrieved after normothermic regional perfusion (NRP)
- •Recipient virtual panel reactive antibodies ≥85%
- •Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria
结局指标
主要结局
Number of patients with immediate graft function
时间窗: 3 months
Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.
次要结局
- Duration of delayed graft function(3 months)
- all-cause and death-censored graft survival up to 5 years(5 years)
- patient survival up to 5 years(5 years)
- Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant(1 year)
- estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant(1 year)
研究者
Robert Minnee
Transplant surgeon
Erasmus Medical Center
研究点 (2)
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