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NCT04882254 Clinical Trial

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

Chronic Kidney Failure Clinical Trial

— APOLLO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04882254
Other study ID # APOLLO
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 1, 2021
Est. completion date February 2026

Study information
Verified date December 2023
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date February 2026
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands Erasmus MC Transplant Institute Rotterdam

Sponsors (1)
Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

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