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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
To 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
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
RECRUITINGLeiden University Medical Center
Leiden, Netherlands
NOT_YET_RECRUITINGErasmus Medical Center
Rotterdam, Netherlands
RECRUITINGGraft 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).
Time frame: 12 months
Patient and graft survival
Patient and graft survival up to 12 months after transplantation
Time frame: 12 months
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
Time frame: 7 days
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
Time frame: 7 days
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.
Time frame: 12 months
Number of participants with biopsy-proven acute rejection
Time frame: 12 monts
estimated Glomerular Filtration Rate
eGFR at day 7, and 1, 3, 6 and 12 months after transplantation
Time frame: 12 months
(serious) adverse events
Number of adverse (device) events and serious adverse (device) events
Time frame: 12 months
Postoperative complications
Time frame: 12 months
The mean serum concentration of creatinine in umol/L for each study arm
Biochemical analysis of graft function with patient serum and urine levels of creatinine at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
Time frame: 12 months
The mean serum concentration of urea in umol/L for each study arm
Biochemical analysis of graft function with patient serum and urine levels of urea at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
Time frame: 12 months
The mean serum concentration of sodium in umol/L for each study arm
Biochemical analysis of graft function with patient serum and urine levels of sodium at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
Time frame: 12 months
The mean serum concentration of potassium in umol/L for each study arm
Biochemical analysis of graft function with patient serum and urine levels of potassium at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
Time frame: 12 months
The mean serum concentration of proteins in umol/L for each study arm
Biochemical analysis of graft function with patient serum and urine levels of protein at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
Time frame: 12 months
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