HLA Eplet Mismatches to Predict Long-term Kidney Transplant Outcomes

December 5, 2025 updated by: Paris Translational Research Center for Organ Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5525

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Paris Translational Research Center for Organ Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients from seven European referral centers

Description

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:

  • Combined transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Kidney allograft failure
Time Frame: Up to 10 years after kidney transplantation
Up to 10 years after kidney transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Added prognostic value
Time Frame: Up to 10 years after kidney transplantation
Added prognostic value of HLA eplet mismatches over standard of care monitoring of kidney transplant recipients based on clinical, histological, immunological parameters
Up to 10 years after kidney transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paris Translational Research Center for Organ Transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Estimated)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HLAeplet_kidney survival

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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