Kidney Failure Clinical Trial
Official title:
Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France
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.
Background 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. This
study aims to simulate the application of allocation policies from the US to France and
vice-versa in two comprehensive cohorts.
Main Outcome(s) and Measure(s)
In the US, data on the donors and kidney transplant recipients will be obtained using
registry data from the Organ Procurement and Transplantation Network (OPTN). The OPTN data
system includes data on all donors, waitlisted candidates, and transplant recipients in the
US, as submitted by the members of the Organ Procurement and Transplantation Network. The
Health Resources and Services Administration (HRSA) of the US Department of Health and Human
Services oversees the activities of the OPTN contractor.
In France, data on the donors and recipients in the French cohort will be obtained from the
national CRISTAL registry, initiated in 1996 and maintained by the Agence de la Biomédecine,
which prospectively collects data on all potential donors and organ transplant candidates,
along with their outcomes. By law, data collection is provided by all organ procurement
organizations and transplant centers in France; research studies based on the national
CRISTAL registry are part of the transplant assessment activities and do not require
institutional review board approval.
Graft survival will be estimated using the Kaplan-Meier method. Duration of follow-up started
with the patient risk evaluation (starting point) up to the date of the kidney graft loss,
defined as a patient's return to dialysis, or retransplantation. For patients who died with a
functioning graft, graft survival will be censored at the time of death.
The investigators will then model kidney allograft discard practices using KDRI and perform
simulation to estimate kidneys that would have been discarded in each country using the
discard score (Monte-Carlo technique). The investigators will also quantify predicted kidney
allograft survival of the discarded kidneys. Eventually, the investigators will estimate the
gain of allograft life years based on observed survival data.
Groups/Cohorts
All kidney transplantation occurring in France and in the US from 2004 to 2014 with available
data to calculate the KDRI and the Kidney Donor Profile Index (KDPI), with lower values
suggestive of better quality. The KDRI and KDPI are currently used as part of the OPTN
allocation system for deceased donor kidneys in the US and have been validated as reliable
measures of organ quality in the US.
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