Actively Recruiting
Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating 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
234 weeks
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 the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring. Extracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft. The mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated. The hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.
CONDITIONS
Official 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...
- ECP treatment decision based on transplant team habits
- Age 18 years or older
- Affiliation to a French social security scheme
- Kidney transplant at least 6 months prior to inclusion
- cABMR confirmed by a renal graft biopsy within the last 3 months with specific histological criteria:
- Allograft glomerulopathy (cg > 0, maximum score cg2) or intimal fibrosis
- C4d positive or ptc+g ≥ 2
- Presence of Donor Specific Antibody (DSA)
- Interstitial Fibrosis and Tubular Atrophy (IFTA) ≤ 2
- Glomerular filtration rate > 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, C or HIV virus
- Pregnant, breastfeeding or parturient woman
- Person deprived of liberty by judicial or administrative decision
- Person receiving psychiatric care under duress
- Person subject to legal protection
- Person unable to express consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
E
Emma BLANCHET
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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