Kidney Failure Clinical Trial
— USFRKTOfficial title:
Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France
NCT number | NCT03723668 |
Other study ID # | USFRKT1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 9, 2017 |
Est. completion date | March 29, 2020 |
Verified date | April 2020 |
Source | Paris Translational Research Center for Organ Transplantation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 94017 |
Est. completion date | March 29, 2020 |
Est. primary completion date | October 11, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All consecutive kidneys recovered for the purpose of transplantation from donors deceased from brain death or circulatory death, - Between January 1, 2004 and December 31, 2014. Exclusion Criteria: - Living renal transplants, - Multiorgan transplant recipients, - Kidneys offered to transplant centers but never recovered, and - Patients with missing data to calculate the KDRI score |
Country | Name | City | State |
---|---|---|---|
France | Paris Transplant Group | Paris | |
United States | Kidney Transplantation Care at Veteran's Affairs Medical Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Paris Translational Research Center for Organ Transplantation | Agence de La Biomédecine, University of Pennsylvania |
United States, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of kidneys procured and discarded. | In some instances, the two kidneys might be procured from one donor but one or both kidneys may eventually be discarded and thus, not transplanted. This information was retrieved in both the OPTN data system and CRISTAL registry. | 10 years | |
Secondary | Probability of allograft failure after transplantation. | This is defined as the need for renal replacement therapy or preemptive re-transplantation. | 10 years |
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