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Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

RecruitingNAAges 50 Years - 100 YearsAllUniversity Medical Center Groningen
NCT05782543 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Normothermic machine perfusion
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Where

3 sites
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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