Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion (REWARM)

University Medical Center Groningen (UMCG)

Status

Not yet enrolling

Conditions

Kidney Transplant; Complications

Treatments

Procedure: Normothermic machine perfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05782543

15911

Details and patient eligibility

About

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).

Enrollment

280 estimated patients

Sex

All

Ages

50 to 100 years old

Volunteers

No Healthy Volunteers

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.