Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation. (IPECAM)

University Hospital, Angers

Status: Enrolling

Conditions: Kidney Transplantation

Treatments: Other: Extracorporeal phototherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04870437

2021-A00580-41

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Extracorporeal phototherapy

Experimental group

Treatment:

Other: Extracorporeal phototherapy