Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection (PETRUM)

June 24, 2026 updated by: Centre Hospitalier Universitaire de Besancon
This study aims to describe, over a one-year period, the clinical, biological, and histological evolution of a cohort of kidney transplant recipients who developed antibody-mediated rejection and were treated with extracorporeal photopheresis.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

31

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • Centre Hospitalier Universitaire de Besançon
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients presenting with antibody-mediated rejection and treated with extracorporeal photopheresis

Description

Inclusion Criteria:

  • Kidney transplant recipients followed at the University Hospitals of Besançon and Lille between September 1, 2016, and August 31, 2023
  • Patients with antibody-mediated rejection (as confirmed by histological analysis of the renal biopsy)
  • Rejection treated with extracorporeal photopheresis
  • Subjects who do not object to the use of their personal data and/or biological samples
  • Subjects affiliated with, or beneficiaries of, the French social security system

Exclusion Criteria:

  • Patients with acute rejection
  • Pregnant women, women in labor, or breastfeeding mothers
  • Individuals deprived of liberty by judicial or administrative decision; individuals receiving compulsory psychiatric care; or individuals admitted to a healthcare or social institution for reasons other than research participation
  • Minors
  • Adults under legal protection or unable to provide informed consent
  • Subjects without health insurance coverage
  • Subjects currently within an exclusion period from another study, or as listed in the "national volunteer registry"

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
Measure Description
Time Frame
Number of participants with response to extracorporeal photopheresis (ECP) at 1 year
Time Frame: One year after initiation of ECP

Response is defined as either:

  • stable serum creatinine at 1 year after initiation of ECP, corresponding to a variation within ±20% of baseline serum creatinine (responder); or
  • a reduction in the slope of creatinine clearance decline following initiation of ECP compared with the pre-treatment trajectory (partial responder).

Participants meeting either criterion are considered responders for the primary efficacy analysis.
One year after initiation of ECP

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026/1082

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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