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RECRUITING
NCT05782543
NA

Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

50 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-12-15

Completion Date

2028-05-01

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

PROCEDURE

Normothermic 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

Locations (3)

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands