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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Antibody Mediated Rejection After Kidney Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type BIOLOGICAL

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

Stool collection

Intervention Type BIOLOGICAL

Stool collection for research purposes

Blood collection

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

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

Stool collection

Intervention Type BIOLOGICAL

Stool collection for research purposes

Blood collection

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Stool collection

Stool collection for research purposes

Intervention Type BIOLOGICAL

Blood collection

Additional blood volume for research purposes during a routine blood collection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nephrology department, Hôpital Pitié Salpêtière

Paris, , France

Site Status

Nephrology department, Tenon hospital

Paris, , France

Site Status

Countries

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France

Central Contacts

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Yanis TAMZALI, MD, MsC

Role: CONTACT

681402564 ext. +33

Facility Contacts

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Yanis TAMZALI, MD, MsC

Role: primary

01 84 82 82 21 ext. +33

Emmanuel ESTEVE

Role: primary

01 56 01 54 49 ext. +33

Other Identifiers

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APHP250908

Identifier Type: -

Identifier Source: org_study_id

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