Clinical trial NCT04870437: Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Keywords: Chronic AntiBody-Mediated Rejection
ExtraCorporeal Phototherapy
Kidney Transplantation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Mallinckrodt
First posted: 2021-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Primary outcomes:
measure: Frequency of TFH cells and their activation markers
timeFrame: From the 1st session of ECP to 1 year after the 1st session
Secondary outcomes:
measure: Subsequent ECP response in patients with cABMR
timeFrame: 3 months of treatment per ECP
measure: Concentration of pro and anti-inflammatory cytokines
timeFrame: From the 1st session of ECP to 1 year after the 1st session
measure: Concentration of circulating B-cell populations
timeFrame: From the 1st session of ECP to 1 year after the 1st session
measure: Measurement of genetic markers in TFH cells
timeFrame: At 1 week of the 1st session of ECP and at 3 month after the 1st session
measure: Comparison of clinical data of patients
timeFrame: From the 1st session of ECP to 1 year after the 1st session
measure: Comparison of biological data of patients
timeFrame: From the 1st session of ECP to 1 year after the 1st session
Other outcomes:
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