Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
IPECAM
1 other identifier
interventional
30
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2021
CompletedStudy Start
First participant enrolled
April 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 27, 2026
March 6, 2026
September 1, 2025
4.5 years
March 30, 2021
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of TFH cells and their activation markers
Variation in the frequency of TFH cells and their activation markers under treatment.
From the 1st session of ECP to 1 year after the 1st session
Secondary Outcomes (6)
Subsequent ECP response in patients with cABMR
3 months of treatment per ECP
Concentration of pro and anti-inflammatory cytokines
From the 1st session of ECP to 1 year after the 1st session
Concentration of circulating B-cell populations
From the 1st session of ECP to 1 year after the 1st session
Measurement of genetic markers in TFH cells
At 1 week of the 1st session of ECP and at 3 month after the 1st session
Comparison of clinical data of patients
From the 1st session of ECP to 1 year after the 1st session
- +1 more secondary outcomes
Study Arms (1)
Extracorporeal phototherapy
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- ECP treatment decision based on transplant team habits (care management)
- Age ≥ 18 years
- Affiliation to a French social security scheme
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Angerslead
- Therakoscollaborator
Study Sites (4)
Chu Besancon
Besançon, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Chu Saint Etienne
Saint-Etienne, France
CHU de STRASBOURG
Strasbourg, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2021
First Posted
May 3, 2021
Study Start
April 27, 2022
Primary Completion (Estimated)
October 27, 2026
Study Completion (Estimated)
October 27, 2026
Last Updated
March 6, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.