Peripheral and Intrarenal B Cell Study in Antibody Mediated Transplant Rejection : Phenotypic and Transcriptional Study, Study of Reactivity
B-KiMi
1 other identifier
observational
45
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2026
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2025
CompletedFirst Posted
Study publicly available on registry
August 21, 2025
CompletedStudy Start
First participant enrolled
March 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 13, 2029
March 18, 2026
March 1, 2026
3 years
July 8, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Characterization of lymphocytes in humoral rejection
Using Flow cytometry analysis
Day 1
Secondary Outcomes (1)
Analyze of gut microbiota of kidney transplant patients
Day 1
Study Arms (2)
kidney biopsy or graft removal for rejection
Renal transplant recipients with suspicion of rejection or undergoing kidney biopsy or graft removal
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
Interventions
removal for a piece of kidney for research purposes during biopsy or graft removal performed as part of routine care
Stool collection for research purposes
Additional blood volume for research purposes during a routine blood collection
Eligibility Criteria
This study covers a population of adult kidney transplant patients admitted for biopsy or graft removal in the participating nephrology departments.
You may qualify if:
- 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
You may not qualify if:
- Confounding factor of renal inflammation: acute or recurrent pyelonephritis, BK virus nephropathy
- Pregnant or breast-feeding women
- Persons under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nephrology department, Hôpital Pitié Salpêtière
Paris, 75013, France
Nephrology department, Tenon hospital
Paris, 75020, France
Biospecimen
* Removal of a piece of kidney for research purposes during a biopsy or removal of the kidney as part of routine care. * Stool sampling * Additional blood sampling during care puncture
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2025
First Posted
August 21, 2025
Study Start
March 13, 2026
Primary Completion (Estimated)
March 13, 2029
Study Completion (Estimated)
March 13, 2029
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.