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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Besancon
RECRUITING
Besançon
CHU Clermont Ferrand
RECRUITING
Clermont-ferrand
Chu Saint Etienne
RECRUITING
Saint-etienne
CHU de STRASBOURG
RECRUITING
Strasbourg
Contact Information
Primary
Jean-François AUGUSTO, Pr
JFAugusto@chu-angers.fr
+33 2 41 35 50 63
Backup
Emma BLANCHET
EmBlanchet@chu-angers.fr
+33 2 41 35 63 38
Time Frame
Start Date: 2022-04-27
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 30
Treatments
Experimental: Extracorporeal phototherapy
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Angers
Collaborators: Therakos

This content was sourced from clinicaltrials.gov