Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?

Normothermic Machine Perfusion as Additional Value to Hypothermic Machine Perfusion for Kidney Transplant Outcomes. A Single-centre, Open-label, Randomised, Controlled Trial.

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 (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.

Inclusion Criteria:

• 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 Criteria:

• 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