Clinical trial NCT02526966: Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy
Official title: Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IgA Nephropathy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: serum concentration of anti-hinge region antibodies (mg/ml)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH d'ANNECY
city: Annonay
country: France
facility: CH d'ANNONAY
city: Bourg En Bresse
country: France
facility: CH de BOURG EN BRESSE
city: Chambery
country: France
facility: CH de CHAMBERY
city: Clermont-ferrand
country: France
facility: CHU de CLERMONT-FERRAND
city: Dijon
country: France
facility: CHU de DIJON
city: Grenoble
country: France
facility: CHU de GRENOBLE
city: Lyon
country: France
facility: Hôpital Edouard. HERRIOT
city: Pierre-benite
country: France
facility: Centre Hospitalier de Lyon Sud
city: Puy En Velay
country: France
facility: CH du PUY EN VELAY
city: Roanne
country: France
facility: CH de ROANNE
city: Romans
country: France
facility: Hôpitaux Drome Nord
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
city: Valence
country: France
facility: CH de VALENCE
city: Villeurbanne
country: France
facility: Clinique du TONKIN
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Christophe MARIAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: