Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extracorporeal phototherapy.
- Who it may be relevant to
- Registry conditions: Kidney Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation: IPECAM
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Frequency of TFH cells and their activation markers [Time frame: From the 1st session of ECP to 1 year after the 1st session]
Secondary outcome measures (6)
- Subsequent ECP response in patients with cABMR [Time frame: 3 months of treatment per ECP]
- Concentration of pro and anti-inflammatory cytokines [Time frame: From the 1st session of ECP to 1 year after the 1st session]
- Concentration of circulating B-cell populations [Time frame: From the 1st session of ECP to 1 year after the 1st session]
- Measurement of genetic markers in TFH cells [Time frame: At 1 week of the 1st session of ECP and at 3 month after the 1st session]
- Comparison of clinical data of patients [Time frame: From the 1st session of ECP to 1 year after the 1st session]
- Comparison of biological data of patients [Time frame: From the 1st session of ECP to 1 year after the 1st session]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 4 centers
- Chu Besancon — Besançon
- CHU Clermont Ferrand — Clermont-Ferrand
- Chu Saint Etienne — Saint-Etienne
- CHU de STRASBOURG — Strasbourg
Identifiers
NCT: NCT04870437 · 2021-A00580-41