Extracorporeal phototherapy effects on T-follicular helper and B cells in chronic antibody-mediated kidney transplant rejection
Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation: IPECAM
This tests whether extracorporeal phototherapy (ECP) can change T-follicular helper and circulating B cells in adults with chronic antibody-mediated rejection after a kidney transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 4 sites (Besançon and 3 other locations) |
| Trial ID | NCT04870437 on ClinicalTrials.gov |
What this trial studies
Adults with biopsy-proven chronic antibody-mediated rejection at least six months after kidney transplant will receive extracorporeal phototherapy, which isolates mononuclear blood cells, exposes them to UVA light, and returns them to the patient. The trial will track changes in T follicular helper (TFH) lymphocytes and circulating B-lymphocytes and monitor graft function and immune markers over time. Inclusion requires specific histologic criteria, presence of donor-specific antibodies, and a minimum kidney function threshold. The goal is to determine whether ECP induces immunomodulatory changes that could slow immune-mediated graft injury.
Who should consider this trial
Good fit: Adults (≥18) with a kidney transplant at least six months prior, biopsy-proven chronic antibody-mediated rejection with donor-specific antibodies, and GFR >30 mL/min/1.73 m2 who are covered by the French social security system.
Not a fit: Patients with active infections or chronic viral hepatitis/HIV, pregnant or breastfeeding women, those without biopsy-proven cABMR, or with severe graft dysfunction (GFR ≤30 mL/min/1.73 m2) are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, ECP could reduce immune-driven injury and help preserve kidney graft function in patients with chronic antibody-mediated rejection.
How similar studies have performed: ECP is an established therapy for cutaneous T-cell lymphoma and graft-versus-host disease, but its use for chronic antibody-mediated rejection in kidney transplants is relatively novel and not yet proven in large trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Besançon and 3 other locations
- Chu Besancon — Besançon, France (Recruiting)
- CHU Clermont Ferrand — Clermont-Ferrand, France (Recruiting)
- Chu Saint Etienne — Saint-Etienne, France (Recruiting)
- CHU de STRASBOURG — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Jean-François AUGUSTO, Pr
- Email: JFAugusto@chu-angers.fr
- Phone: +33 2 41 35 50 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.