- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882254
Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes? (APOLLO)
December 14, 2023 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
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
-
-
-
Rotterdam, Netherlands, 3015GD
- Recruiting
- Erasmus MC Transplant Institute
-
Contact:
- Robert Minnee, MD, PhD
- Phone Number: +31107031149
- Email: r.minnee@erasmusmc.nl
-
-
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.
|
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
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.
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 (Estimated)
February 1, 2025
Study Completion (Estimated)
February 1, 2026
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 (Estimated)
December 15, 2023
Last Update Submitted That Met QC Criteria
December 14, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
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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