Status:

RECRUITING

Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.

Lead Sponsor:

University Hospital, Angers

Collaborating Sponsors:

Therakos

Conditions:

Kidney Transplantation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 cur...

Eligibility Criteria

Inclusion

  • ECP treatment decision based on transplant team habits (care management)
  • Age ≥ 18 years
  • Affiliation to a French social security scheme
  • Kidney transplant at least 6 months prior to inclusion
  • cABMR proven by a renal graft biopsy less than 3 months and meeting the following histological criteria:
  • allograft glomerulopathy (cg\>0, and maximum score cg2) or intimal fibrosis
  • C4d positive or ptc+g greater than or equal to 2
  • Presence of Donor Specific Antibody (DSA)
  • Interstitial Fibrosis and Tubular Atrophy (IFTA) less than or equal to 2
  • Glomerular filtration rate \> 30 mL/min/1.73 m2
  • Signed informed consent to participate in the study

Exclusion

  • 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 out of state to express consent

Key Trial Info

Start Date :

April 27 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04870437

Start Date

April 27 2022

End Date

June 1 2026

Last Update

October 1 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Chu Besancon

Besançon, France

2

CHU Clermont Ferrand

Clermont-Ferrand, France

3

Chu Saint Etienne

Saint-Etienne, France

4

CHU de STRASBOURG

Strasbourg, France

Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation. | DecenTrialz