Registry Analysis of Deceased Donor Kidney Transplant Outcomes
April 11, 2026 updated by: Chris Jaynes
Registry Analysis of Deceased Donor Kidney Transplant Outcomes With Normothermic Machine Perfusion (NMP)
This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes associated with normothermic machine perfusion (NMP) of deceased donor kidneys.
Currently, there is no method to study NMP kidney outcomes using the National Scientific Registry for Transplant Recipients (SRTR) national public registry, because no data field exists to identify which kidneys received NMP.
Study Overview
Status
Active, not recruiting
Detailed Description
This is a retrospective observational study using existing data from the Scientific Registry of Transplant Recipients (SRTR)/ Organ Procurement and Transplant Network (OPTN) public registry following a Research Plan approved by Health Resources & Services Agency (HRSA).
Study Type
Observational
Enrollment (Estimated)
3500
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
-
-
Indiana
-
West Lafayette, Indiana, United States, 47906
- 34 Lives, PBC
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
End stage renal disease, receiving a kidney transplant.
Description
Inclusion Criteria:
- Requires kidney transplantation
Exclusion Criteria:
- > 15 years old
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
Cohorts and Interventions
Group / Cohort |
|---|
|
NMP Kidney Recipients
Patients receiving a kidney preserved and assessed using NMP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed Graft Function
Time Frame: 7 days post-transplantation
|
Requirement for dialysis immediately post kidney transplantation
|
7 days post-transplantation
|
|
Delayed Graft Function (DGF)
Time Frame: 7 days
|
Requirement for dialysis within 7 days post kidney transplantation
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum creatinine
Time Frame: Up to 3 years post-transplantation
|
Serum creatinine level
|
Up to 3 years post-transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Henri Leuvenink, PhD, 34 Lives, PBC
- Study Chair: Jacqueline Garonzik-Wang, MD, PhD, University of Alabama at Birmingham
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)
April 1, 2026
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Study Registration Dates
First Submitted
April 4, 2026
First Submitted That Met QC Criteria
April 11, 2026
First Posted (Actual)
April 15, 2026
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 11, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 34L-CP-02-021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a registry-only, Non Human Subjects Research (NHSR) study.
No IPD information will be available to any investigator in this study.
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.