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: Active, not recruiting

Administrative data

• NCT number: NCT04882254
• Other study ID #: APOLLO
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 1, 2021
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: May 6, 2024
• 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

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Failure, Chronic
• Kidney Transplant Failure
• Renal Insufficiency

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