Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Number of participants with response to extracorporeal photopheresis (ECP) at 1 year
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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"
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported