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

Erasmus University

Status and phase

Active, not recruiting

Phase 2

Conditions

Chronic Kidney Failure

Kidney Transplant Failure

Treatments

Procedure: Normothermic machine perfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT04882254

APOLLO

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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