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

May 6, 2024 updated by: Robert Minnee, Erasmus Medical Center

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3015GD
        • Erasmus MC Transplant Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

May 6, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 8, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APOLLO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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