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Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France

NCT03723668 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94017

Last updated 2020-05-01

No results posted yet for this study

Summary

Despite the considerable advances in short-term outcomes, kidney transplant recipients continue to suffer from late allograft failure, and little improvement has been made over the past 15 years. The worldwide scarcity of donated kidneys and the decline in the number of living donor transplants have prompted a variety of efforts to expand the organ supply, such as accepting organs from donors who were older or had comorbidities or other injuries.

Two major initiatives from the United Network for Organ Sharing (UNOS), the organization responsible for organ allocation in the US, failed to improve the kidney acceptance rate. First, UNOS introduced the Kidney Donor Risk Index (KDRI) for all kidney offers in 2012. The KDRI is a score that predicts survival of deceased donor kidneys based on 10 donor characteristics and was intended to simplify the process of judging organ quality for clinicians. Second, in 2014, UNOS changed the kidney allocation system so that lower-quality kidneys are offered over wider geographic areas. Despite the ongoing severe organ shortage and these allocation initiatives, the number of discarded kidneys rose from 2,127 (14.9%) in 2006 to 3,631 (20%) in 2016. In this context, the experience of transplant programs outside the US could offer novel approaches to making organ utilization more efficient through the examination of the disposition of organs that are usually discarded in the US.

This project aims:

1. To evaluate the potential benefit of transplanting kidneys that would have been discarded otherwise in the US
2. Computer simulation models on real life data to estimate the number of kidney transplants that would have taken place using data from a nationwide cohort study in two countries (France, the US);
3. To evaluate the potential gains in allograft survival years that would result in the US from a less restrictive kidney acceptance practice such as the one from France.

Conditions

Sponsors & Collaborators

  • University of Pennsylvania

    collaborator OTHER

  • Agence de La Biomédecine

    collaborator OTHER_GOV

  • Paris Translational Research Center for Organ Transplantation

    lead OTHER

Principal Investigators

  • Peter Reese, MD · Kidney Transplantation Care at Veteran's Affairs Medical Center

  • Alex Loupy · Paris Transplant Group, INSERM, UMR-S970, Paris, France

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2018-10-11
Completion
2020-03-29

Countries

  • United States
  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03723668 on ClinicalTrials.gov