Status:
ACTIVE_NOT_RECRUITING
Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?
Lead Sponsor:
Erasmus Medical Center
Conditions:
Kidney Transplant Failure
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donatio...
Eligibility Criteria
Inclusion
- kidney-only transplant
- renal replacement therapy at time of transplant
- receiving standard immunosuppression regimen post-transplant.
- Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.
Exclusion
- pre-emptive at time of transplant
- receive a multi-organ or dual kidney transplant
- age donor or recipient below 18 years
- Maastricht type I and II DCD
- donor kidneys preserved on static cold storage (SCS)
- kidneys retrieved after normothermic regional perfusion (NRP)
- Recipient virtual panel reactive antibodies ≥85%
- Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04882254
Start Date
May 1 2021
End Date
May 1 2025
Last Update
May 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Erasmus MC Transplant Institute
Rotterdam, Netherlands, 3015GD