NCT02526966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
Last Updated

January 25, 2017

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

August 17, 2015

Last Update Submit

January 24, 2017

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

  • serum concentration of anti-hinge region antibodies (mg/ml)

    Baseline

Study Arms (1)

patient with primitive form of IgA nephropathy

OTHER
Biological: blood sample

Interventions

blood sampleBIOLOGICAL

dosage of anti-hinge region antibodies

patient with primitive form of IgA nephropathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major Patient
  • Diagnosis of a primitive form of IgA nephropathy histologically proven

You may not qualify if:

  • Suspicion of secondary IgA nephropathy forms
  • Less than 5 glomeruli present on renal biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CH d'ANNECY

Annecy, 74000, France

Location

CH d'ANNONAY

Annonay, 07100, France

Location

CH de BOURG EN BRESSE

Bourg-en-Bresse, 01000, France

Location

CH de CHAMBERY

Chambéry, 73000, France

Location

CHU de CLERMONT-FERRAND

Clermont-Ferrand, 63000, France

Location

CHU de DIJON

Dijon, 21000, France

Location

CHU de GRENOBLE

Grenoble, 38000, France

Location

CH du PUY EN VELAY

Le Puy-en-Velay, 43000, France

Location

Hôpital Edouard. HERRIOT

Lyon, 69003, France

Location

Centre Hospitalier de Lyon Sud

Pierre-Bénite, 69310, France

Location

CH de ROANNE

Roanne, 42300, France

Location

Hôpitaux Drome Nord

Romans, 26100, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

CH de VALENCE

Valence, 26000, France

Location

Clinique du TONKIN

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christophe MARIAT, MD PhD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 18, 2015

Study Start

March 1, 2012

Primary Completion

June 30, 2014

Study Completion

June 30, 2014

Last Updated

January 25, 2017

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(15)