HLA Eplet Mismatches to Predict Long-term Kidney Transplant Outcomes

NCT07269275 | Completed

• 1 other identifier: HLAeplet_kidney survival
• Study Type: observational
• Target: 5,525
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Failure

Keywords

graft survival; kidney function; prediction; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Kidney allograft failure

  Up to 10 years after kidney transplantation

Secondary Outcomes (1)

• Added prognostic value

  Up to 10 years after kidney transplantation

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients from seven European referral centers

You may qualify if:

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

You may not qualify if:

• Combined transplantation

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (1)

Paris Translational Research Center for Organ Transplantation

Paris, France

Location

Related Publications (2)

• 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.

  PMID: 40592858 BACKGROUND

• 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.

  PMID: 31530561 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)