Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy (NIGA-RA)
Primary Purpose
IgA Nephropathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for IgA Nephropathy
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
Sites / Locations
- CH d'ANNECY
- CH d'ANNONAY
- CH de BOURG EN BRESSE
- CH de CHAMBERY
- CHU de CLERMONT-FERRAND
- CHU de DIJON
- CHU de GRENOBLE
- Hôpital Edouard. HERRIOT
- Centre Hospitalier de Lyon Sud
- CH du PUY EN VELAY
- CH de ROANNE
- Hôpitaux Drome Nord
- CHU de SAINT-ETIENNE
- CH de VALENCE
- Clinique du TONKIN
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient with primitive form of IgA nephropathy
Arm Description
Outcomes
Primary Outcome Measures
serum concentration of anti-hinge region antibodies (mg/ml)
Secondary Outcome Measures
Full Information
NCT ID
NCT02526966
First Posted
August 17, 2015
Last Updated
January 24, 2017
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02526966
Brief Title
Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
June 30, 2014 (Actual)
Study Completion Date
June 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with primitive form of IgA nephropathy
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
dosage of anti-hinge region antibodies
Primary Outcome Measure Information:
Title
serum concentration of anti-hinge region antibodies (mg/ml)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe MARIAT, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH d'ANNECY
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
CH d'ANNONAY
City
Annonay
ZIP/Postal Code
07100
Country
France
Facility Name
CH de BOURG EN BRESSE
City
Bourg En Bresse
ZIP/Postal Code
01000
Country
France
Facility Name
CH de CHAMBERY
City
Chambery
ZIP/Postal Code
73000
Country
France
Facility Name
CHU de CLERMONT-FERRAND
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de GRENOBLE
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Hôpital Edouard. HERRIOT
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Centre Hospitalier de Lyon Sud
City
Pierre-benite
ZIP/Postal Code
69310
Country
France
Facility Name
CH du PUY EN VELAY
City
Puy En Velay
ZIP/Postal Code
43000
Country
France
Facility Name
CH de ROANNE
City
Roanne
ZIP/Postal Code
42300
Country
France
Facility Name
Hôpitaux Drome Nord
City
Romans
ZIP/Postal Code
26100
Country
France
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
Facility Name
CH de VALENCE
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Clinique du TONKIN
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy
We'll reach out to this number within 24 hrs