Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating… (NCT04870437) | Clinical Trial Compass
RecruitingNot Applicable
Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
France30 participantsStarted 2022-04-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of TFH cells and their activation markers
Timeframe: From the 1st session of ECP to 1 year after the 1st session