Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
- Conditions
- Kidney Transplantation
- Interventions
- Other: Extracorporeal phototherapy
- Registration Number
- NCT04870437
- Lead Sponsor
- University Hospital, Angers
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Extracorporeal phototherapy Extracorporeal phototherapy -
- Primary Outcome Measures
Name Time Method Frequency of TFH cells and their activation markers From the 1st session of ECP to 1 year after the 1st session Variation in the frequency of TFH cells and their activation markers under treatment.
- Secondary Outcome Measures
Name Time Method Concentration of pro and anti-inflammatory cytokines From the 1st session of ECP to 1 year after the 1st session Study of the concentration of pro-inflammatory cytokines (IL-6, TNFα, IL-1β, IL-17, IFN-gamma, IL-21, IL-12, IL-17, CXCL13) and anti-inflammatory cytokines (IL10, TGF-b) over time in ECP
Concentration of circulating B-cell populations From the 1st session of ECP to 1 year after the 1st session Study of the concentration of circulating B-cell populations due to ECP
Measurement of genetic markers in TFH cells At 1 week of the 1st session of ECP and at 3 month after the 1st session Study of genetic markers in TFH cells in cell co-culture in vitro to describe their function
Subsequent ECP response in patients with cABMR 3 months of treatment per ECP Study of the 3-month TFH/TFR value of ECP treatment as a marker for subsequent ECP response in patients with cABMR
Comparison of clinical data of patients From the 1st session of ECP to 1 year after the 1st session Clinical measures (medical examinations) of patients
Comparison of biological data of patients From the 1st session of ECP to 1 year after the 1st session Biological measures (blood samples) of patients