- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07341516
Worldwide Assessment of Deceased Donor Kidney Utilization
Worldwide Assessment of Deceased Donor Kidney Utilization: Disparities, Temporal Trends, and Outcomes
Study Overview
Status
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:
- 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Paris, France, 75015
- Paris Institute for Transplantation and Organ Regeneration, INSERM, UMR-S970, Paris, France
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Center for Transplant Science, Vanderbilt University Medical Center, Nashville, TN, USA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kidney allograft discard
Time Frame: Day 0
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defined as kidneys recovered for transplantation but not transplanted.
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Day 0
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Allograft failure
Time Frame: up to 15 years
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defined as return to dialysis and/or re-transplantation.
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up to 15 years
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Estimated additional allograft life-years achievable
Time Frame: up to 15 years
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through adoption of best practice utilization patterns (simulation based).
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up to 15 years
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Collaborators and Investigators
Collaborators
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
General Publications
- Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289.
- Hosgood SA, Callaghan CJ, Wilson CH, Smith L, Mullings J, Mehew J, Oniscu GC, Phillips BL, Bates L, Nicholson ML. Normothermic machine perfusion versus static cold storage in donation after circulatory death kidney transplantation: a randomized controlled trial. Nat Med. 2023 Jun;29(6):1511-1519. doi: 10.1038/s41591-023-02376-7. Epub 2023 May 25.
- Aubert O, Yoo D, Zielinski D, Cozzi E, Cardillo M, Durr M, Dominguez-Gil B, Coll E, Da Silva MI, Sallinen V, Lemstrom K, Midtvedt K, Ulloa C, Immer F, Weissenbacher A, Vallant N, Basic-Jukic N, Tanabe K, Papatheodoridis G, Menoudakou G, Torres M, Soratti C, Hansen Krogh D, Lefaucheur C, Ferreira G, Silva HT Jr, Hartell D, Forsythe J, Mumford L, Reese PP, Kerbaul F, Jacquelinet C, Vogelaar S, Papalois V, Loupy A. COVID-19 pandemic and worldwide organ transplantation: a population-based study. Lancet Public Health. 2021 Oct;6(10):e709-e719. doi: 10.1016/S2468-2667(21)00200-0. Epub 2021 Aug 30.
- Loupy A, Aubert O, Reese PP, Bastien O, Bayer F, Jacquelinet C. Organ procurement and transplantation during the COVID-19 pandemic. Lancet. 2020 May 23;395(10237):e95-e96. doi: 10.1016/S0140-6736(20)31040-0. Epub 2020 May 11. No abstract available.
- Ibrahim M, Vece G, Mehew J, Johnson R, Forsythe J, Klassen D, Callaghan C, Stewart D. An international comparison of deceased donor kidney utilization: What can the United States and the United Kingdom learn from each other? Am J Transplant. 2020 May;20(5):1309-1322. doi: 10.1111/ajt.15719. Epub 2019 Dec 21.
- Vidgren M, Delorme C, Oniscu GC. Challenges and opportunities in organ donation after circulatory death. J Intern Med. 2025 Feb;297(2):124-140. doi: 10.1111/joim.20051. Epub 2025 Jan 20.
- Potluri VS, Goldberg DS, Mohan S, Bloom RD, Sawinski D, Abt PL, Blumberg EA, Parikh CR, Sharpe J, Reddy KR, Molnar MZ, Sise M, Reese PP. National Trends in Utilization and 1-Year Outcomes with Transplantation of HCV-Viremic Kidneys. J Am Soc Nephrol. 2019 Oct;30(10):1939-1951. doi: 10.1681/ASN.2019050462. Epub 2019 Sep 12.
- Bowring MG, Shaffer AA, Massie AB, Cameron A, Desai N, Sulkowski M, Garonzik-Wang J, Segev DL. Center-level trends in utilization of HCV-exposed donors for HCV-uninfected kidney and liver transplant recipients in the United States. Am J Transplant. 2019 Aug;19(8):2329-2341. doi: 10.1111/ajt.15355. Epub 2019 Apr 9.
- Malinoski D, Saunders C, Swain S, Groat T, Wood PR, Reese J, Nelson R, Prinz J, Kishish K, Van De Walker C, Geraghty PJ, Broglio K, Niemann CU. Hypothermia or Machine Perfusion in Kidney Donors. N Engl J Med. 2023 Feb 2;388(5):418-426. doi: 10.1056/NEJMoa2118265.
- Stewart DE, Garcia VC, Rosendale JD, Klassen DK, Carrico BJ. Diagnosing the Decades-Long Rise in the Deceased Donor Kidney Discard Rate in the United States. Transplantation. 2017 Mar;101(3):575-587. doi: 10.1097/TP.0000000000001539.
- Aubert O, Reese PP, Audry B, Bouatou Y, Raynaud M, Viglietti D, Legendre C, Glotz D, Empana JP, Jouven X, Lefaucheur C, Jacquelinet C, Loupy A. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance. JAMA Intern Med. 2019 Oct 1;179(10):1365-1374. doi: 10.1001/jamainternmed.2019.2322.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kidney allocation project
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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