Peripheral and Intrarenal B Cell Study in Antibody Mediated Transplant Rejection : Phenotypic and Transcriptional Study, Study of Reactivity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Piece of kidney removal, Stool collection, Blood collection.
- Who it may be relevant to
- Registry conditions: Antibody Mediated Rejection After Kidney Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological Piece of kidney removal
removal for a piece of kidney for research purposes during biopsy or graft removal performed as part of routine care - Biological Stool collection
Stool collection for research purposes - Biological Blood collection
Additional blood volume for research purposes during a routine blood collection
Primary outcome measures
- Characterization of lymphocytes in humoral rejection [Time frame: Day 1]
Secondary outcome measures (1)
- Analyze of gut microbiota of kidney transplant patients [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 2 centers
- Nephrology department, Hôpital Pitié Salpêtière — Paris
- Nephrology department, Tenon hospital — Paris
Identifiers
NCT: NCT07134491 · APHP250908