Warm machine perfusion for older deceased-donor kidneys before transplant

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 50 Years to 100 Years
• Sex: All
• Sponsor: University Medical Center Groningen (Academic / other)
• Locations: 3 sites (Groningen, Provincie Groningen and 2 other locations)
• Trial ID: NCT05782543 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Groningen, Provincie Groningen and 2 other locations

• University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)
• Leiden University Medical Center — Leiden, Netherlands (Not_yet_recruiting)
• Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)

Study contacts

• Study coordinator: Cyril Moers, MD, PhD

Conditions Kidney Transplant; Complications