Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Kidney transplant recipients presenting with antibody-mediated rejection and treated with extracorporeal photopheresis
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of participants with response to extracorporeal photopheresis (ECP) at 1 year
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.
Time frame
One year after initiation of ECPSponsors and contacts
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Source ClinicalTrials.gov