Actively Recruiting
Impact of Extracorporeal Phototherapy on T Follicular Helper and B-Lymphocytes During Chronic Antibody-Mediated Rejection in Kidney Transplantation
Led by University Hospital, Angers · Updated on 2026-03-06
30
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Angers
Lead Sponsor
T
Therakos
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic Antibody-Mediated Rejection (cABMR) is a major cause of kidney transplant loss occurring after one year post-transplantation. This research evaluates the effects of extracorporeal phototherapy (ECP) on immune cells, particularly T Follicular Helper (TFH) lymphocytes and B lymphocytes, in patients with cABMR. The study explores how ECP, a treatment involving blood cell purification and exposure to ultraviolet light, might modulate immune responses in this condition. Participants receive extracorporeal phototherapy, where mononucleated blood cells are collected by centrifugation, treated outside the body with a light-activated agent (8-methoxypsoralen, UVADEX®), and then reinfused. The study monitors changes in immune cells and activation markers from the first ECP session through one year afterward. The treatment decision follows existing transplant team practices, and patients must meet specific biopsy-confirmed criteria for cABMR. During the study, participants will undergo assessments including measurement of TFH cell frequency and activation, circulating B-cell populations, cytokine levels, and genetic markers at various time points up to one year after ECP begins. Clinical and biological data comparisons will be made to evaluate responses. Safety and treatment responses will be observed throughout, with informed consent required. Participants are adults with kidney transplants and specific kidney function levels, and the study duration covers at least one year post-treatment initiation.
CONDITIONS
Brief Title
Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Decision to treat with extracorporeal phototherapy based on transplant team practice
- Age 18 years or older
- Affiliated with a French social security scheme
- Kidney transplant performed at least 6 months before joining the study
- Chronic antibody-mediated rejection confirmed by a kidney biopsy within the last 3 months with specific histological criteria
- Glomerular filtration rate greater than 30 mL/min/1.73 m2
- Signed informed consent to participate in the study
You will not qualify if you...
- Active infection or infection with hepatitis B, hepatitis C, or HIV
- Pregnant, breastfeeding, or recently gave birth
- Under legal custody or deprived of liberty by judicial or administrative decision
- Receiving psychiatric care under duress
- Under legal protection
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months of treatment per ECP
Participants receive extracorporeal phototherapy which involves collecting mononucleated cells from the blood, treating them ex-vivo with a photo-activatable agent, and re-injecting them to the participant.
Weekly visits for up to 3 months
Duration - Up to 1 year after the first session
Participants are monitored for changes in T follicular helper cells, B-lymphocytes, cytokine concentrations, and clinical and biological data for up to 1 year after the first treatment session.
Periodic visits during the year for assessments
Trial Site Locations
Total: 4 locations
1
Chu Besancon
Besançon, France
Actively Recruiting
2
CHU Clermont Ferrand
Clermont-Ferrand, France
Actively Recruiting
3
Chu Saint Etienne
Saint-Etienne, France
Actively Recruiting
4
CHU de STRASBOURG
Strasbourg, France
Actively Recruiting
Research Team
J
Jean-François AUGUSTO, Pr
E
Emma BLANCHET
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here