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NCT Number: NCT07134491

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nephrology department, Hôpital Pitié Salpêtière, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piece of kidney removal

Biological

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

stool collection

Biological

Stool collection for research purposes

Blood collection

Biological

Additional blood volume for research purposes during a routine blood collection

Primary outcomes

  1. Characterization of lymphocytes in humoral rejection

    Time frame: Day 1

    Using Flow cytometry analysis

Secondary outcomes

  1. Analyze of gut microbiota of kidney transplant patients

    Time frame: Day 1

    Using Flow cytometry analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Yanis TAMZALI, MD, MsC

CONTACT

[email protected]

681402564 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: B-KiMi

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 21, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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