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Recruiting Observational

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

NCT07134491 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-03-13
Last updated
2026-03-18

Condition(s) studied

Antibody Mediated Rejection After Kidney Transplantation

Investigational drug(s) / intervention(s)

Piece of kidney removalStool collectionBlood collection →

Piece of kidney removal: removal for a piece of kidney for research purposes during biopsy or graft removal performed as part of routine care

Stool collection: Stool collection for research purposes

Blood collection: Additional blood volume for research purposes during a routine blood collection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult kidney transplant recipients admitted for biopsy or graft removal in the participating nephrology departments. * Patient participation agreement and signed consent form * Affiliation to a health insurance system Exclusion Criteria: * Confounding factor of renal inflammation: acute or recurrent pyelonephritis, BK virus nephropathy * Pregnant or breast-feeding women * Persons under legal protection

Primary outcome measure(s)

  • Characterization of lymphocytes in humoral rejection — Day 1
    Using Flow cytometry analysis

Trial sites (2)

FacilityCityRegionStatus
Nephrology department, Hôpital Pitié Salpêtière Paris France Recruiting
Nephrology department, Tenon hospital Paris France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07134491 on ClinicalTrials.gov ↗ ← All trials in France