Kidney FailureUSFRKTNCT03723668
Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France
An observational study of Kidney Failure and Transplant;Failure,Kidney, run by Paris Translational Research Center for Organ Transplantation at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Failure, Transplant;Failure,Kidney
- How many people
- 94,017 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Oct 2017to 29 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Living renal transplants,
- Multiorgan transplant recipients,
- Kidneys offered to transplant centers but never recovered, and
- Patients with missing data to calculate the KDRI score
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Kidney Transplantation Care at Veteran's Affairs Medical Center
Philadelphia, Pennsylvania, 19104
About this study
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.
Read more
This project aims:
- To evaluate the potential benefit of transplanting kidneys that would have been discarded otherwise in the US
- 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);
- 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.
Read the detailed description
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.
- Conditions
- Kidney Failure, Transplant;Failure,Kidney
- Keywords
- kidney transplantation, allograft survival
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OPTN data system | 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. | |
| CRISTAL registry | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
Probability of allograft failure after transplantation.
This is defined as the need for renal replacement therapy or preemptive re-transplantation.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start9 Oct 2017
- Primary completion11 Oct 2018
- Study completion29 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 94,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Agence de La Biomédecine
- Responsible party
- Sponsor
- Investigators
- Peter Reese, MD, Principal investigator, Kidney Transplantation Care at Veteran's Affairs Medical CenterAlex Loupy, Principal investigator, Paris Transplant Group, INSERM, UMR-S970, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723668
- Sponsor's protocol ID
- USFRKT1
- Acronym
- USFRKT
- Status last verified
- Apr 2020
- First submitted
- 24 Oct 2018
- Last updated
- 1 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31449299
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France
- ClinicalTrials.gov ID
- NCT03723668
- Acronym / sponsor ID
- USFRKT / USFRKT1
- Conditions
- Kidney Failure, Transplant;Failure,Kidney
- Keywords
- kidney transplantation, allograft survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94,017 participants (actual)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Agence de La Biomédecine
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 29 Mar 2020 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the potential benefit of transplanting kidneys that would have been discarded otherwise in the US
- 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);
- 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTN data system | – | –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. |
| CRISTAL registry | – | –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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Living renal transplants,
- Multiorgan transplant recipients,
- Kidneys offered to transplant centers but never recovered, and
- Patients with missing data to calculate the KDRI score
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of kidneys procured and discarded.
Time frame: 10 years
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.
1 secondary outcome
Probability of allograft failure after transplantation.
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Derived from this study: PubMed 31449299Aubert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Reese, MD principal investigator
Kidney Transplantation Care at Veteran's Affairs Medical Center
Alex Loupy principal investigator
Paris Transplant Group, INSERM, UMR-S970, Paris, France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure and Transplant;Failure,Kidney, run by Paris Translational Research Center for Organ Transplantation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of kidneys procured and discarded. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03723668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.