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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07663669

Acronym

PETRUM

Enrollment

Registered

2026-06-23

Start date

2026-06-01

Completion date

2026-10-01

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody-mediated Rejection in Kidney Transplant

Keywords

Extracorporeal photopheresis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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"

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with response to extracorporeal photopheresis (ECP) at 1 year	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.

Countries

France

Contacts

CONTACTCharline Vauchy, PhD.

cvauchy@chu-besancon.fr+33381218875

Outcome results