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

IgA Nephropathy Clinical Trial

— NIGA-RA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526966
• Other study ID #: 1108060
• Secondary ID: 2011-A00860-41
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: January 24, 2017
• Start date: March 2012
• Est. completion date: June 30, 2014

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 30, 2014
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Biological:
• blood sample
dosage of anti-hinge region antibodies

Locations

Country	Name	City	State
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	CHU de DIJON	Dijon
France	CHU de GRENOBLE	Grenoble
France	Hôpital Edouard. HERRIOT	Lyon
France	Centre Hospitalier de Lyon Sud	Pierre-benite
France	CH du PUY EN VELAY	Puy En Velay
France	CH de ROANNE	Roanne
France	Hôpitaux Drome Nord	Romans
France	CHU de SAINT-ETIENNE	Saint-etienne
France	CH de VALENCE	Valence
France	Clinique du TONKIN	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum concentration of anti-hinge region antibodies (mg/ml)		Baseline