Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07134491

Peripheral and Intrarenal B Cell Study in Antibody Mediated Transplant Rejection : Phenotypic and Transcriptional Study, Study of Reactivity

Status
Recruiting
Phase
Study type
Observational
Enrollment
45 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Humoral rejection of kidney transplants is responsible for a large number of kidney graft losses in a context of increasing shortage. Although it has been established that it is largely mediated by the alloreactive B lymphocyte, anti-B therapies are only partially effective. The mechanisms behind the loss of tolerance are also poorly understood, and the triggers of rejection remain to be elucidated. During this study, patients admitted for kidney graft biopsy for suspicion of rejection will be included ; patients presenting non inflammatory biopsies will be studied as controls. B cells will be extracted and cultured. Their antibodies will be studied along with reactivity towards HLA, non HLA targets and the gut microbiome. The same study will be led for late rejections needing graft removal : B cells extraction, culture, antibodies reactivity testing. Controls will be graft removal for non inflammatory causes. In both cases hight throughput sequencing the immunoglobulin genes will be performed.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPiece of kidney removalremoval for a piece of kidney for research purposes during biopsy or graft removal performed as part of routine care
BIOLOGICALStool collectionStool collection for research purposes
BIOLOGICALBlood collectionAdditional blood volume for research purposes during a routine blood collection

Timeline

Start date
2026-03-13
Primary completion
2029-03-13
Completion
2029-03-13
First posted
2025-08-21
Last updated
2026-03-18

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT07134491. Inclusion in this directory is not an endorsement.