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

Phase 2

Active, not recruiting

• Conditions: Kidney Transplant Failure; Chronic Kidney Failure
• Interventions: Procedure: Normothermic machine perfusion

• Registration Number: NCT04882254
• Lead Sponsor: Erasmus Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-08
• Study First Posted: 2021-05-11
• Status Verified: 2024-05
• Primary Completion: 2024-05-06
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normothermic machine perfusion	Normothermic machine perfusion	Additional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate.

Primary Outcome Measures

Name	Time	Method
Number of patients with immediate graft function	3 months	Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.

Secondary Outcome Measures

Name	Time	Method
patient survival up to 5 years	5 years
Duration of delayed graft function	3 months
all-cause and death-censored graft survival up to 5 years	5 years
Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant	1 year
estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant	1 year

Trial Locations

Locations (1)

Erasmus MC Transplant Institute; 🇳🇱 Rotterdam, Netherlands