Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy

NCT ID: NCT02526966

Last Updated: 2017-01-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-06-30

Brief Summary

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The anti-hinge region antibodies would be a relevant biomarker of IgA nephropathy. Beyond a prognostic value (which could increase the risk of Renal Absolute), the longitudinal monitoring for these antibodies could be of interest: (1) in the monitoring of patients (in place including a possible repetition renal biopsy); (2) to guide treatment decisions and (3) in clinical research, as an outcome (in substitution for the occurrence of kidney failure) in therapeutic trials IgA nephropathy.

This research project constitutes the first step in validating these antibodies biomarker of IgA nephropathy and its main objective is to study the performance of the blood levels of anti-hinge region antibodies in the diagnosis of progressive forms of histologically IgA nephropathy as defined by the Renal Risk Absolute.

The secondary objectives of this project are to establish a bio-collection that will allow us to search for other prognostic factors (genetic, cellular and serum) of IgA nephropathy and to evaluate the performance of Renal Absolute risk by integrating Oxford score, the new international histological classification.

Detailed Description

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Conditions

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IgA Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patient with primitive form of IgA nephropathy

Group Type OTHER

blood sample

Intervention Type BIOLOGICAL

dosage of anti-hinge region antibodies

Interventions

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blood sample

dosage of anti-hinge region antibodies

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Major Patient
* Diagnosis of a primitive form of IgA nephropathy histologically proven

Exclusion Criteria

* Suspicion of secondary IgA nephropathy forms
* Less than 5 glomeruli present on renal biopsy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe MARIAT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CH d'ANNECY

Annecy, , France

Site Status

CH d'ANNONAY

Annonay, , France

Site Status

CH de BOURG EN BRESSE

Bourg-en-Bresse, , France

Site Status

CH de CHAMBERY

Chambéry, , France

Site Status

CHU de CLERMONT-FERRAND

Clermont-Ferrand, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

CHU de GRENOBLE

Grenoble, , France

Site Status

CH du PUY EN VELAY

Le Puy-en-Velay, , France

Site Status

Hôpital Edouard. HERRIOT

Lyon, , France

Site Status

Centre Hospitalier de Lyon Sud

Pierre-Bénite, , France

Site Status

CH de ROANNE

Roanne, , France

Site Status

Hôpitaux Drome Nord

Romans, , France

Site Status

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

CH de VALENCE

Valence, , France

Site Status

Clinique du TONKIN

Villeurbanne, , France

Site Status

Countries

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France

Other Identifiers

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2011-A00860-41

Identifier Type: OTHER

Identifier Source: secondary_id

1108060

Identifier Type: -

Identifier Source: org_study_id

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