Clinical trial NCT05782543: Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion
Official title: Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion - The REWARM Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Transplant; Complications
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 280
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The REWARM study is an open label, randomized controlled clinical efficacy study, with primary outcome renal function 6 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 4-6 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 140 patients in each of the two arms (280 patients total).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Graft function at twelve months after transplantation
timeFrame: 12 months
Secondary outcomes:
measure: Patient and graft survival
timeFrame: 12 months
measure: Occurence of delayed graft function (DGF) in the first 7 days after transplantation
timeFrame: 7 days
measure: Duration of delayed graft function (DGF) in the first 7 days after transplantation
timeFrame: 7 days
measure: Number of participants with primary non-function (PNF)
timeFrame: 12 months
measure: Number of participants with biopsy-proven acute rejection
timeFrame: 12 monts
measure: estimated Glomerular Filtration Rate
timeFrame: 6 months
measure: (serious) adverse events
timeFrame: 12 months
measure: Postoperative complications
timeFrame: 12 months
measure: The mean serum concentration of creatinine in umol/L for each study arm
timeFrame: 12 months
measure: The mean serum concentration of urea in umol/L for each study arm
timeFrame: 12 months
measure: The mean serum concentration of sodium in umol/L for each study arm
timeFrame: 12 months
measure: The mean serum concentration of potassium in umol/L for each study arm
timeFrame: 12 months
measure: The mean serum concentration of proteins in umol/L for each study arm
timeFrame: 12 months
Other outcomes:
Locations:
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