Kidney Transplant FailureNCT07269275
HLA Eplet Mismatches to Predict Long-term Kidney Transplant Outcomes
An observational study of Kidney Transplant Failure, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
Trial summary
Human leukocyte antigen (HLA) matching evaluates the degree of compatibility between donors and organ transplant recipients and assesses broad antigen differences that may influence immune responses post-transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure
- How many people
- 5,525 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Jul 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Kidney transplant recipients from seven European referral centers
Who may be able to join
- Living or deceased donor kidney recipients transplanted after 2004
- Kidney recipients older than 18 years of age
- Kidney recipients with available HLA genotyping data
Who cannot join
- Combined transplantation
Trial locations and contacts
1 site in 1 country.
France1 site
Paris Translational Research Center for Organ Transplantation
Paris
About this study
Official title: Prognostic Value of HLA Eplet Mismatches for Long-term Kidney Transplant Outcomes
Human leukocyte antigen (HLA) matching evaluates the degree of compatibility between donors and organ transplant recipients and assesses broad antigen differences that may influence immune responses post-transplant. A refined HLA matching method based on examining clusters of amino acids on HLA molecules, named eplets, has been recently developed. This method identifies immunogenic discrepancies that may not be apparent through traditional HLA matching. In recent years, assessment of HLA eplet mismatches has emerged as a promising strategy to improve immune risk stratification in kidney transplantation, which is crucial for kidney recipients' management and maximizing allograft longevity. Despite its potential, the prognostic value and clinical relevance of HLA eplet mismatches for predicting long-term kidney allograft failure has not been robustly demonstrated.
In this study, the investigators aim to investigate whether HLA eplet mismatches may represent a relevant clinical tool for patient risk stratification and prediction of long-term allograft failure beyond standard clinical, histological and immunological parameters for monitoring in kidney transplant recipients.
- Conditions
- Kidney Transplant Failure
- Being tested
- No intervention
- Keywords
- graft survival, kidney function, prediction, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney allograft failure
Measured: Up to 10 years after kidney transplantation
Secondary outcomes (1)
Added prognostic value
Added prognostic value of HLA eplet mismatches over standard of care monitoring of kidney transplant recipients based on clinical, histological, immunological parameters
Measured: Up to 10 years after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jan 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant 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
- Prospective
- Enrolment
- 5,525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269275
- Sponsor's protocol ID
- HLAeplet_kidney survival
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demir Z, Raynaud M, Divard G, Louis K, Truchot A, Niemann M, Ponsirenas R, Aubert O, Del Bello A, Hertig A, Anglicheau D, Dale B, Kamar N, Mangiola M, Zeevi A, Lefaucheur C, Loupy A. Impact of HLA evolutionary divergence and donor-recipient molecular mismatches on antibody-mediated rejection of kidney allografts. Nat Commun. 2025 Jul 1;16(1):5692. doi: 10.1038/s41467-025-60485-y.
PubMed 40592858Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Bohmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923.
PubMed 31530561
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of HLA Eplet Mismatches for Long-term Kidney Transplant Outcomes
- ClinicalTrials.gov ID
- NCT07269275
- Acronym / sponsor ID
- HLAeplet_kidney survival
- Conditions
- Kidney Transplant Failure
- Keywords
- graft survival, kidney function, prediction, kidney transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,525 participants (actual)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 8 Dec 2025 (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.
Human leukocyte antigen (HLA) matching evaluates the degree of compatibility between donors and organ transplant recipients and assesses broad antigen differences that may influence immune responses post-transplant. A refined HLA matching method based on examining clusters of amino acids on HLA molecules, named eplets, has been recently developed. This method identifies immunogenic discrepancies that may not be apparent through traditional HLA matching. In recent years, assessment of HLA eplet mismatches has emerged as a promising strategy to improve immune risk stratification in kidney transplantation, which is crucial for kidney recipients' management and maximizing allograft longevity. Despite its potential, the prognostic value and clinical relevance of HLA eplet mismatches for predicting long-term kidney allograft failure has not been robustly demonstrated.
In this study, the investigators aim to investigate whether HLA eplet mismatches may represent a relevant clinical tool for patient risk stratification and prediction of long-term allograft failure beyond standard clinical, histological and immunological parameters for monitoring in kidney transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients from seven European referral centers
Key inclusion criteria (3 listed)
- Living or deceased donor kidney recipients transplanted after 2004
- Kidney recipients older than 18 years of age
- Kidney recipients with available HLA genotyping data
Key exclusion criteria (1 listed)
- Combined transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Kidney allograft failure
Time frame: Up to 10 years after kidney transplantation
1 secondary outcome
Added prognostic value
Time frame: Up to 10 years after kidney transplantation
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 12 Dec 2025.
- Background: PubMed 40592858Demir Z, Raynaud M, Divard G, Louis K, Truchot A, Niemann M, Ponsirenas R, Aubert O, Del Bello A, Hertig A, Anglicheau D, Dale B, Kamar N, Mangiola M, Zeevi A, Lefaucheur C, Loupy A. Impact of HLA evolutionary divergence and donor-recipient molecular mismatches on antibody-mediated rejection of kidney allografts. Nat Commun. 2025 Jul 1;16(1):5692. doi: 10.1038/s41467-025-60485-y.
- Background: PubMed 31530561Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Bohmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
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 3 inclusion and 1 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Kidney allograft failure (time frame: Up to 10 years after kidney transplantation). 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 NCT07269275, which also lists 2 linked publications.
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 12 Dec 2025.