Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04870437

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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