Worldwide Assessment of Deceased Donor Kidney Utilization

Worldwide Assessment of Deceased Donor Kidney Utilization: Disparities, Temporal Trends, and Outcomes

The persistent imbalance between kidney transplant demand and organ availability remains a major global challenge. Optimizing the utilization of kidneys from deceased donors is a critical strategy to expand the donor pool and increase access to transplantation. Previous studies have demonstrated substantial international differences in kidney acceptance and discard practices, with significant potential gains in allograft life-years through optimized utilization. However, major changes in allocation policies, donor characteristics, preservation technologies, and global events such as the COVID-19 pandemic may have altered contemporary utilization patterns. This study aims to characterize international trends in deceased donor kidney utilization, compare allograft survival across countries, and estimate potential transplantable allograft life-years gained through improved utilization practices.

Study Overview

Status

Enrolling by invitation

Detailed Description

Substantial imbalance between organ demand and availability remains a major challenge in kidney transplantation worldwide. Therefore, expanding the donor pool is a critical priority, and a key strategy is optimizing the utilization of organs from deceased donors. Our previous study (PMID: 31449299) demonstrated significant disparities in kidney acceptance and discard rates between US and France, with US discarding kidneys at nearly twice the rate of France. Simulation modeling suggested that adopting more aggressive, French-based acceptance practices could have prevented 17 435 discarded kidneys in the US over ten years, generating an additional 132 445 allograft life-years.

Since that period the transplantation landscape has evolved substantially. Key developments include major policy reforms such as the 2014 US Kidney Allocation System redesign, increased use of advanced preservation technologies, expanding acceptance of hepatitis C-positive donor organs, substantial growth in donation after circulatory death (DCD), and global disruptions in transplant activity caused by the COVID-19 pandemic.

The impact of these developments on current utilization practices and international disparities remains unknown. Contemporary patterns of deceased donor kidney utilization and discard rates across different allocation systems have not yet been characterized.

This study aims to:

  1. Characterize international patterns and temporal trends in deceased donor kidney utilization and discard rates from 2010 to 2025.
  2. Compare allograft survival across countries and donor risk profiles.
  3. Quantify potential transplantable allograft life-years gained through optimized utilization practices.

Study Type

Observational

Enrollment (Estimated)

300000

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

      • Paris, France, 75015
        • Paris Institute for Transplantation and Organ Regeneration, INSERM, UMR-S970, Paris, France
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Center for Transplant Science, Vanderbilt University Medical Center, Nashville, TN, USA

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

All kidneys recovered for transplantation from deceased donors (brain death or circulatory death) between January 1, 2010, and December 31, 2025, across 10 allocation systems, with sufficient data to calculate the Kidney Donor Risk Index. Recipients of transplants from these donors will also be included for outcome assessment.

Description

Inclusion Criteria:

  • All consecutive kidneys recovered for the purpose of transplantation from donors deceased from brain death or circulatory death between January 1, 2010 and December 31, 2025

Exclusion Criteria:

  • Kidneys offered to transplant centers but never recovered
  • Living renal transplants
  • Multiorgan transplant recipients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney allograft discard
Time Frame: Day 0
defined as kidneys recovered for transplantation but not transplanted.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allograft failure
Time Frame: up to 15 years
defined as return to dialysis and/or re-transplantation.
up to 15 years
Estimated additional allograft life-years achievable
Time Frame: up to 15 years
through adoption of best practice utilization patterns (simulation based).
up to 15 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alexandre Loupy, MD, PhD, Paris Institute for Transplantation and Organ Regeneration, INSERM, UMR-S970, Paris, France
  • Principal Investigator: Peter P Reese, MD, PhD, Vanderbilt Center for Transplant Science, Vanderbilt University Medical Center, Nashville, TN, USA

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

Helpful Links

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)

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data analyzed during the current study are available on reasonable request including standards for General Data Protection Regulation and Institutional Review Board approval.

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.

Clinical Trials on Kidney Failure

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