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NCT Number: NCT07663669

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

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.

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Key information

Conditions

Antibody-mediated Rejection in Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

Location status: Recruiting

Location contact

Charline Vauchy, PhD.

CONTACT

[email protected]

+33381218875

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Charline Vauchy, PhD.

CONTACT

[email protected]

+33381218875

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: PETRUM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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