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NCT Number: NCT04870437

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Besancon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal phototherapy

Other

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 outcomes

  1. Frequency of TFH cells and their activation markers

    Time frame: 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 outcomes

  1. Subsequent ECP response in patients with cABMR

    Time frame: 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

  2. Concentration of pro and anti-inflammatory cytokines

    Time frame: 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

  3. Concentration of circulating B-cell populations

    Time frame: 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

  4. 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

    Study of genetic markers in TFH cells in cell co-culture in vitro to describe their function

  5. Comparison of clinical data of patients

    Time frame: From the 1st session of ECP to 1 year after the 1st session

    Clinical measures (medical examinations) of patients

  6. Comparison of biological data of patients

    Time frame: From the 1st session of ECP to 1 year after the 1st session

    Biological measures (blood samples) of patients

Study contacts

Contact information is provided by the study sponsor or research team.

Emma BLANCHET

CONTACT

[email protected]

+33 2 41 35 63 38

Jean-François AUGUSTO, Pr

CONTACT

[email protected]

+33 2 41 35 50 63

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Therakos

Registry information

Official study title

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

Acronym: IPECAM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 3, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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