B Cell Lymphocyte in Humoral Rejection and Alloimmunisation
NCT ID: NCT03016455
Last Updated: 2017-05-04
Study Results
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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UNKNOWN
125 participants
OBSERVATIONAL
2013-06-30
2017-12-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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DSA positive patients without cAMR
Presence of DSA w/o cAMR
Presence of DSA w/o cAMR
DSA positive patients with cAMR
Presence of DSA w/ cAMR
Presence of DSA w/ cAMR
Stable patients
No DSA No cAMR
No DSA No cAMR
Interventions
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Presence of DSA w/ cAMR
Presence of DSA w/o cAMR
No DSA No cAMR
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Yannick LE MEUR, MD PhD
Role: STUDY_DIRECTOR
University Hospital, Brest
Locations
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CHU Amiens
Amiens, , France
Chu Angers
Angers, , France
CHU Brest
Brest, , France
CHU CAEN
Caen, , France
Chu Clermont Ferrand
Clermont-Ferrand, , France
CHU Limoges
Limoges, , France
APHP Hôpital Necker
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Reims
Reims, , France
CHU Rennes
Rennes, , France
CHU Rouen
Rouen, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
CHU Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BHL (RB 12.047)
Identifier Type: -
Identifier Source: org_study_id
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