NCT04870437 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Kidney Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-04-27 |
| Primary Completion | 2026-10-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-04-27 with a primary completion date of 2026-10-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04870437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04870437 currently recruiting?
Yes, NCT04870437 is actively recruiting participants. Contact the research team at JFAugusto@chu-angers.fr for enrollment information.
Where is the NCT04870437 trial being conducted?
This trial is being conducted at Besançon, France, Clermont-Ferrand, France, Saint-Etienne, France, Strasbourg, France.
Who is sponsoring the NCT04870437 clinical trial?
NCT04870437 is sponsored by University Hospital, Angers. The trial plans to enroll 30 participants.
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