Peripheral and Intrarenal B Cell Study in Antibody Mediated Transplant Rejection : Phenotypic and Transcriptional Study, Study of Reactivity (B-KiMi)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yanis TAMZALI, MD, MsC
- Phone Number: +33 681402564
- Email: yanis.tamzali@aphp.fr
Study Locations
-
-
-
Paris, France, 75013
- Recruiting
- Nephrology department, Hôpital Pitié Salpêtière
-
Contact:
- Yanis TAMZALI, MD, MsC
- Phone Number: +33 01 84 82 82 21
- Email: yanis.tamzali@aphp.fr
-
Paris, France, 75020
- Not yet recruiting
- Nephrology department, Tenon hospital
-
Contact:
- Emmanuel ESTEVE
- Phone Number: +33 01 56 01 54 49
- Email: emmanuel.esteve@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
kidney biopsy or graft removal for rejection
Renal transplant recipients with suspicion of rejection or undergoing kidney biopsy or graft removal
|
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
|
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterization of lymphocytes in humoral rejection
Time Frame: Day 1
|
Using Flow cytometry analysis
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analyze of gut microbiota of kidney transplant patients
Time Frame: Day 1
|
Using Flow cytometry analysis
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP250908
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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