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Enrolling by Invitation

NCT Number: NCT07341516

Worldwide Assessment of Deceased Donor Kidney Utilization

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris Institute for Transplantation and Organ Regeneration, INSERM, UMR-S970, Paris, France, Paris, France

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About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Kidney allograft discard

    Time frame: Day 0

    defined as kidneys recovered for transplantation but not transplanted.

Secondary outcomes

  1. Allograft failure

    Time frame: up to 15 years

    defined as return to dialysis and/or re-transplantation.

  2. Estimated additional allograft life-years achievable

    Time frame: up to 15 years

    through adoption of best practice utilization patterns (simulation based).

Sponsors and collaborators

Lead sponsor

Paris Translational Research Center for Organ Transplantation

Other

Collaborators

  • Vanderbilt University Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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