B Cell Lymphocyte in Humoral Rejection and Alloimmunisation

NCT ID: NCT03016455

Last Updated: 2017-05-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to better characterise B cell phenotype and functional abnormalities in kidney transplant patients producing donor specific antibody (DSA) and in those with chronic antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The functional analysis will help to better understand B cell-dependant mechanisms implied in T cell proliferation and better target future treatments.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The principal objective is to better understand the B cell dependant mechanisms of the chronic antibody mediated rejection (cAMR). A particular focus will be done on the mechanisms that could explain the natural history of chronic humoral mediated rejection and of pathways from DSA negative status toward DSA positive status and from DSA positive status to histological lesions. The following will be undergone for three categories of patients (stable patients, DSA positive patients without cAMR and DSA positive patients with cAMR) :

* A phenotypic analysis of B cells of patients suffering from chronic humoral rejection or who are simply DSA positive.
* A functional analysis in autologous cultures in order to confirm our preliminary results.
* A functional analysis in a heterologous proliferation test aiming at a better understanding of the absence of B cell regulation of T cell proliferation in patients suffering from cAMR.
* A cytokine analysis (IL10, alpha-tumor necrosis factor, gamma-interferon dosing), for a better understanding of the mechanisms that are involved in the regulation of the T cell response that is induced by the B cells.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DSA positive patients without cAMR

Presence of DSA w/o cAMR

Presence of DSA w/o cAMR

Intervention Type OTHER

DSA positive patients with cAMR

Presence of DSA w/ cAMR

Presence of DSA w/ cAMR

Intervention Type OTHER

Stable patients

No DSA No cAMR

No DSA No cAMR

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Presence of DSA w/ cAMR

Intervention Type OTHER

Presence of DSA w/o cAMR

Intervention Type OTHER

No DSA No cAMR

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Non stable patients :

* Patient older than 18 years old.
* Patient which is the recipient of a renal transplant
* Patient who develops anti donor antibodies after the transplantation and / or suffering from a histologically-proven antibody mediated rejection.
* Patient who has signed an informed consent form
* Stable patients :

* Patient older than 18 years old.
* Patient that is the recipient of a renal transplant for more than one year
* Patient who has accepted to participate in the Brest Kidney graft recipient collection
* Patient that is not suffering from any rejection, that has a good renal function and a low proteinuria
* Patient that has not developed any DSA.

Exclusion Criteria

\- Patients that has not signed the consent form.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yannick LE MEUR, MD PhD

Role: STUDY_DIRECTOR

University Hospital, Brest

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens

Amiens, , France

Site Status COMPLETED

Chu Angers

Angers, , France

Site Status COMPLETED

CHU Brest

Brest, , France

Site Status RECRUITING

CHU CAEN

Caen, , France

Site Status COMPLETED

Chu Clermont Ferrand

Clermont-Ferrand, , France

Site Status COMPLETED

CHU Limoges

Limoges, , France

Site Status WITHDRAWN

APHP Hôpital Necker

Paris, , France

Site Status COMPLETED

CHU Poitiers

Poitiers, , France

Site Status COMPLETED

CHU Reims

Reims, , France

Site Status COMPLETED

CHU Rennes

Rennes, , France

Site Status COMPLETED

CHU Rouen

Rouen, , France

Site Status COMPLETED

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status COMPLETED

CHU Tours

Tours, , France

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yannick LE MEUR, MD PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yannick LE MEUR, MD PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BHL (RB 12.047)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Antibodies and Liver Retransplantation
NCT03815864 ACTIVE_NOT_RECRUITING