Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
NCT ID: NCT04870437
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-04-27
2026-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Extracorporeal phototherapy
Extracorporeal phototherapy
The principle of ECP is to collect mononucleated cells from the blood by centrifugation. After purification, the mononucleated cells are incubated ex-vivo with a photo-activatable DNA intercalating agent (8-methoxypsoralen, UVADEX®), then re-injected to the patient.
Interventions
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Extracorporeal phototherapy
The principle of ECP is to collect mononucleated cells from the blood by centrifugation. After purification, the mononucleated cells are incubated ex-vivo with a photo-activatable DNA intercalating agent (8-methoxypsoralen, UVADEX®), then re-injected to the patient.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Therakos
INDUSTRY
University Hospital, Angers
OTHER_GOV
Responsible Party
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Locations
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Chu Besancon
Besançon, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
Chu Saint Etienne
Saint-Etienne, , France
CHU de STRASBOURG
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A00580-41
Identifier Type: -
Identifier Source: org_study_id
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