Peripheral and Intrarenal B Cell Study in Antibody Mediated Transplant Rejection : Phenotypic and Transcriptional Study, Study of Reactivity
NCT ID: NCT07134491
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
45 participants
OBSERVATIONAL
2025-10-01
2028-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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kidney biopsy or graft removal for rejection
Renal transplant recipients with suspicion of rejection or undergoing kidney biopsy or graft removal
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
kidney biopsy or graft removal for reasons other than rejection
Renal transplant recipients with undergoing kidney graft removal or biopsy for reansons other than rejection
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patient participation agreement and signed consent form
* Affiliation to a health insurance system
Exclusion Criteria
* Pregnant or breast-feeding women
* Persons under legal protection
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Nephrology department, Hôpital Pitié Salpêtière
Paris, , France
Nephrology department, Tenon hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP250908
Identifier Type: -
Identifier Source: org_study_id
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