Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

Not Applicable

Not yet recruiting

• Conditions: Kidney Transplant; Complications
• Interventions: Procedure: Normothermic machine perfusion

• Registration Number: NCT05782543
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Study First Posted: 2023-03-23
• Last Update Posted: 2023-03-23
• Study Start: 2023-09
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normothermic machine perfusion	Normothermic machine perfusion	-

Primary Outcome Measures

Name	Time	Method
Graft function at twelve months after transplantation	12 months	The primary endpoint of this study is graft function at twelve months after transplantation, defined as the estimated glomerular filtration rate (eGFR).

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	12 months
(serious) adverse events	12 months	Number of adverse (device) events and serious adverse (device) events
Patient and graft survival	12 months	Patient and graft survival up to 12 months after transplantation
Occurence of delayed graft function (DGF) in the first 7 days after transplantation	7 days	DGF defined as dialysis requirement in the first week after transplantation, excluding dialysis for one-time hyperkaliemia in the first two days post-transplant
Duration of delayed graft function (DGF) in the first 7 days after transplantation	7 days	DGF defined as dialysis requirement in the first week after transplantation, excluding dialysis for one-time hyperkaliemia in the first two days post-transplant
Number of participants with primary non-function (PNF)	12 months	Incidence of primary non-function (PNF) defined as a permanent lack of graft function starting after transplantation.
Number of participants with biopsy-proven acute rejection	12 monts
estimated Glomerular Filtration Rate	6 months	eGFR at day 7, and 1, 3 and 6 months after transplantation
The mean serum concentration of creatinine in umol/L for each study arm	12 months	Biochemical analysis of graft function with patient serum and urine levels of creatinine at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
The mean serum concentration of urea in umol/L for each study arm	12 months	Biochemical analysis of graft function with patient serum and urine levels of urea at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
The mean serum concentration of sodium in umol/L for each study arm	12 months	Biochemical analysis of graft function with patient serum and urine levels of sodium at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
The mean serum concentration of potassium in umol/L for each study arm	12 months	Biochemical analysis of graft function with patient serum and urine levels of potassium at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation
The mean serum concentration of proteins in umol/L for each study arm	12 months	Biochemical analysis of graft function with patient serum and urine levels of protein at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation