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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07134491
Acronym
B-KiMi
Enrollment
45
Registered
2025-08-21
Start date
2026-03-13
Completion date
2029-03-13
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody Mediated Rejection After Kidney Transplantation

Keywords

Kidney transplantation, Rejection, Donor-specific antibodies, Human Leukocyte Antigen, Microbiome

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.

Interventions

BIOLOGICALPiece of kidney removal

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

BIOLOGICALStool collection

Stool collection for research purposes

BIOLOGICALBlood collection

Additional blood volume for research purposes during a routine blood collection

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Characterization of lymphocytes in humoral rejectionDay 1Using Flow cytometry analysis

Secondary

MeasureTime frameDescription
Analyze of gut microbiota of kidney transplant patientsDay 1Using Flow cytometry analysis

Countries

France

Contacts

CONTACTYanis TAMZALI, MD, MsC
yanis.tamzali@aphp.fr681402564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026