RecruitingNot ApplicableNCT05782543

Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

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

Sponsor

University Medical Center Groningen

Enrollment

240 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

Kidney Transplant; Complications

Summary

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).

Eligibility

Min Age: 50 YearsMax Age: 100 Years

Inclusion Criteria7

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 Criteria8

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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Interventions

PROCEDURENormothermic machine perfusion

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