NCT03723668: USFRKT

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

Completed Last updated 1 May 2020

What this trial tests

trial in Kidney Failure in 94,017 participants. Completed in 29 March 2020.

Timeline

9 October 2017

Primary endpoint
11 October 2018

29 March 2020

Quick facts

Lead sponsor	Paris Translational Research Center for Organ Transplantation
Status	Completed
Study type	OBSERVATIONAL
Enrollment	94,017
Start date	9 October 2017
Primary completion	11 October 2018
Estimated completion	29 March 2020
Sites	2 locations across France, United States

Conditions studied

• Kidney Failure — all drugs for Kidney Failure →
• Transplant;Failure,Kidney — all drugs for Transplant;Failure,Kidney →

Sponsor

Paris Translational Research Center for Organ Transplantation — full company profile →

Who can join

Eligibility, any sex, with Kidney Failure or Transplant;Failure,Kidney. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance.
   Aubert O, Reese PP, Audry B, Bouatou Y, et al · · 2019 · cited 122× · PMID 31449299 · DOI 10.1001/jamainternmed.2019.2322