Clinical trial Recruiting at 2 sites Interventional Ages 50 to 100

Warm machine perfusion for older deceased-donor kidneys before transplant

Official title: Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion - The REWARM Study

Run by University Medical Center Groningen · NCT05782543 · Data updated 2026-11-12

This study will test whether giving kidneys from deceased donors aged 50 or older six hours of warm machine perfusion before transplant improves kidney function at 12 months for adults getting their first or second kidney transplant.

Quick facts

Study typeInterventional
Ages50 Years to 100 Years
SexAll
Enrollment240 (estimated)
SponsorUniversity Medical Center Groningen
Academic / other
Locations3 sites (Groningen, Provincie Groningen and 2 other locations)
StatusRecruiting
StartedDecember 15, 2024
Main results expectedDecember 1, 2027
Study endsMay 1, 2028
Registry record updatedDecember 18, 2025
Trial IDNCT05782543 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) receiving their first or second kidney transplant from a deceased donor aged 50 or older, with the graft stored on hypothermic machine perfusion and transplanted at one of the three participating Dutch centers, are ideal candidates.

Probably not a fit

Patients receiving a third or subsequent transplant, multi-organ transplants, kidneys from donors under 50, kidneys not stored on HMP, kidneys with complex arterial anatomy, or transplants done outside the three participating centers are not eligible and would not benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REWARM is a randomized, controlled, multicenter trial in three Dutch transplant centers comparing an extra six-hour period of normothermic machine perfusion (after standard hypothermic machine perfusion) to standard care with hypothermic machine perfusion alone. Eligible kidneys come from deceased donors aged 50 years or older and are donated after circulatory or brain death. Adult recipients receiving their first or second kidney transplant at UMCG, Erasmus MC, or LUMC are randomized, with a target enrollment of 240 patients (120 per arm) over about 2.5–3 years. The primary outcome is renal function measured at 12 months post-transplant, with secondary outcomes addressing graft complications and survival.

Why it matters

Potential benefit: If successful, the approach could improve one-year graft function and reduce complications, potentially increasing the usable pool of older donor kidneys.

How similar studies have gone: Early and smaller studies of normothermic machine perfusion have shown promising improvements in early graft function and organ assessment, but large randomized trials with one-year outcomes are still limited.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • University Medical Center Groningen
    Groningen, Provincie Groningen, Netherlands
    Recruiting
  • Erasmus Medical Center
    Rotterdam, Netherlands
    Recruiting
  • Leiden University Medical Center
    Leiden, Netherlands
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.