CClinicalTrials.gg
CompletedNCT07269275Updated Dec 12, 2025

HLA Eplet Mismatches to Predict Long-term Kidney Transplant Outcomes

An observational study in Kidney Transplant Failure, sponsored by Paris Translational Research Center for Organ Transplantation. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by Paris Translational Research Center for Organ Transplantation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,525
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Kidney Transplant Failure

Keywords

  • graft survival
  • kidney function
  • prediction
  • kidney transplantation
03

In context

Lead sponsor

Paris Translational Research Center for Organ Transplantation is the lead sponsor of 31 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Kidney transplant recipients from seven European referral centers

Inclusion criteria

  • Living or deceased donor kidney recipients transplanted after 2004
  • Kidney recipients older than 18 years of age
  • Kidney recipients with available HLA genotyping data

Exclusion criteria

Exclusion Criteria:

  • Combined transplantation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,525 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Kidney allograft failure

    Time frame: 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

    Time frame: Up to 10 years after kidney transplantation

07

Study locations

1 site
  • Paris Translational Research Center for Organ Transplantation
    Paris, France
08

References and documents

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 40592858 ↗
  • Loupy 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07269275
Lead sponsor
Paris Translational Research Center for Organ Transplantation
Responsible party
Sponsor
First posted
Dec 8, 2025
Start date
Jan 1, 2023
Primary completion
Jul 1, 2025
Completion
Jul 1, 2025
Last update
Dec 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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