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

NCT02526966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-01-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

blood sample

dosage of anti-hinge region antibodies

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Christophe MARIAT, MD PhD · CHU de SAINT-ETIENNE

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526966 on ClinicalTrials.gov