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

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Transplant Failure, Chronic Kidney Failure

Intervention / Treatment
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* Procedure: Normothermic machine perfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomised to either intervention arm (normothermic machine perfusion, NMP) or standard-of-care (hypothermic machine perfusion, HMP)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normothermic machine perfusion<br>Additional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate. | Procedure: Normothermic machine perfusion<br>* Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.<br>|
| No Intervention: Standard-of-care<br>Standard-of-care, which is hypothermic kidney machine perfusion in the Netherlands. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normothermic kidney machine perfusion