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

Phase 2Active Not RecruitingNCT04882254

Erasmus Medical Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplant Failure Chronic Kidney Failure

Interventions

Normothermic machine perfusionPROCEDURE

Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Erasmus MC Transplant Institute

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Number of patients with immediate graft function

Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.

Time frame: 3 months

Secondary Outcomes

Duration of delayed graft function

Time frame: 3 months

estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant

Time frame: 1 year

Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant

Time frame: 1 year

all-cause and death-censored graft survival up to 5 years

Time frame: 5 years

patient survival up to 5 years

Time frame: 5 years

Data from ClinicalTrials.gov

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