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

Not Applicable

Completed

• Conditions: IgA Nephropathy
• Interventions: Biological: blood sample

• Registration Number: NCT02526966
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2014-06-30
• Study Completion: 2014-06-30
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Status Verified: 2016-03
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient with primitive form of IgA nephropathy	blood sample	-

Primary Outcome Measures

Name	Time	Method
serum concentration of anti-hinge region antibodies (mg/ml)	Baseline

Trial Locations

Locations (15)

CHU de GRENOBLE; 🇫🇷 Grenoble, France

CH du PUY EN VELAY; 🇫🇷 Puy En Velay, France

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France

CH de VALENCE; 🇫🇷 Valence, France

Hôpital Edouard. HERRIOT; 🇫🇷 Lyon, France

Centre Hospitalier de Lyon Sud; 🇫🇷 Pierre-benite, France

CHU de DIJON; 🇫🇷 Dijon, France

CH d'ANNECY; 🇫🇷 Annecy, France

CH d'ANNONAY; 🇫🇷 Annonay, France

CH de BOURG EN BRESSE; 🇫🇷 Bourg En Bresse, France

CH de CHAMBERY; 🇫🇷 Chambery, France

CHU de CLERMONT-FERRAND; 🇫🇷 Clermont-ferrand, France

CH de ROANNE; 🇫🇷 Roanne, France

Hôpitaux Drome Nord; 🇫🇷 Romans, France

Clinique du TONKIN; 🇫🇷 Villeurbanne, France