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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Angers
NCT04870437 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Extracorporeal phototherapy
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Where

4 sites
Chu Besancon
Besançon, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Chu Saint Etienne
Saint-Etienne, France
CHU de STRASBOURG
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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