NCT05782543

Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Kidney Transplant; Complications

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-15
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2023-03-23
• Last updated: 2025-12-18

Locations

3 sites across 1 country: Netherlands