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).
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 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);
Parallel
Normothermic machine perfusion
Procedure/SurgeryTo determine whether a 4-6 hour period of normothermic machine perfusion, following standard hypothermic machine perfusion, results in better graft function after transplantation, compared to hypothermic machine perfusion preservation alone of kidneys recovered from deceased donors aged 50 years or older
Graft function at twelve months after transplantation
The primary endpoint of this study is graft function at twelve months after transplantation, defined as the estimated glomerular filtration rate (eGFR).
Patient and graft survival
Patient and graft survival up to 12 months after transplantation
Occurence of delayed graft function (DGF) in the first 7 days after transplantation
DGF defined as dialysis requirement in the first week after transplantation, excluding dialysis for one-time hyperkaliemia in the first two days post-transplant
Duration of delayed graft function (DGF) in the first 7 days after transplantation
DGF defined as dialysis requirement in the first week after transplantation, excluding dialysis for one-time hyperkaliemia in the first two days post-transplant
Number of participants with primary non-function (PNF)
Incidence of primary non-function (PNF) defined as a permanent lack of graft function starting after transplantation.
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