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Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion
Sponsor: University Medical Center Groningen
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
Conditions
Interventions
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