NCT05782543招募中不适用
Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion - The REWARM Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Graft function at twelve months after transplantation
研究概览
简要总结
The REWARM study is a randomized controlled clinical efficacy study, with primary outcome renal function 12 months after transplantation of kidneys recovered from deceased donors aged 50 years or older. Prior to transplantation, kidney grafts in the intervention group will receive 6 hours of NMP, following standard HMP and kidneys in the control group will only receive standard treatment, being HMP. It is a multi-center trial. Given the total annual 50+ deceased donor kidney transplantation volume of the three participating transplant centers combined, inclusions in the study are expected to last 2.5-3 years, aiming for a total of 120 patients in each of the two arms (240 patients total).
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
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving their first or second kidney transplant;
- •Patients receiving a graft from a ≥ 50-year-old donor;
- •Patients receiving a graft from a DCD or DBD donor;
- •Patients receiving a kidney transplant in the UMCG, the Erasmus MC, or the LUMC;
- •Patients receiving a graft stored on HMP;
- •Patients ≥ 18 years of age;
- •Patients having provided written informed consent.
排除标准
- •Patients receiving their third or subsequent kidney transplant;
- •Patients receiving a graft from a donor < 50 years;
- •Patients receiving a graft not stored on HMP;
- •Patients receiving a graft from a donor that underwent normothermic regional perfusion (NRP);
- •Patients receiving a kidney transplant in another center than the UMCG, Erasmus MC, or LUMC;
- •Patients receiving a multi-organ transplantation;
- •Patients receiving a kidney with complex arterial anatomy (3 or more arteries);
- •Recipients < 18 years of age.
结局指标
主要结局
Graft function at twelve months after transplantation
时间窗: 12 months
The primary endpoint of this study is graft function at twelve months after transplantation, defined as the estimated glomerular filtration rate (eGFR).
次要结局
- (serious) adverse events(12 months)
- Postoperative complications(12 months)
- The mean serum concentration of creatinine in umol/L for each study arm(12 months)
- The mean serum concentration of urea in umol/L for each study arm(12 months)
- The mean serum concentration of sodium in umol/L for each study arm(12 months)
- The mean serum concentration of potassium in umol/L for each study arm(12 months)
- The mean serum concentration of proteins in umol/L for each study arm(12 months)
- Patient and graft survival(12 months)
- Occurence of delayed graft function (DGF) in the first 7 days after transplantation(7 days)
- Duration of delayed graft function (DGF) in the first 7 days after transplantation(7 days)
- Number of participants with primary non-function (PNF)(12 months)
- Number of participants with biopsy-proven acute rejection(12 monts)
- Patient and graft survival(12 months)
- Occurence of delayed graft function (DGF) in the first 7 days after transplantation(7 days)
- Duration of delayed graft function (DGF) in the first 7 days after transplantation(7 days)
- Number of participants with primary non-function (PNF)(12 months)
- Number of participants with biopsy-proven acute rejection(12 monts)
- estimated Glomerular Filtration Rate(12 months)
- (serious) adverse events(12 months)
- Postoperative complications(12 months)
- The mean serum concentration of creatinine in umol/L for each study arm(12 months)
- The mean serum concentration of urea in umol/L for each study arm(12 months)
- The mean serum concentration of sodium in umol/L for each study arm(12 months)
- The mean serum concentration of potassium in umol/L for each study arm(12 months)
- The mean serum concentration of proteins in umol/L for each study arm(12 months)
研究者
研究点 (3)
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