Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT02526966
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2015-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-08-17', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum concentration of anti-hinge region antibodies (mg/ml)', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IgA Nephropathy']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major Patient\n* Diagnosis of a primitive form of IgA nephropathy histologically proven\n\nExclusion Criteria:\n\n* Suspicion of secondary IgA nephropathy forms\n* Less than 5 glomeruli present on renal biopsy'}, 'identificationModule': {'nctId': 'NCT02526966', 'acronym': 'NIGA-RA', 'briefTitle': 'Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Multicenter Study Evaluating the Performance of the Assay of Anti-hinge Region Antibodies in the Diagnosis of Progressive Forms of IgA Nephropathy', 'orgStudyIdInfo': {'id': '1108060'}, 'secondaryIdInfos': [{'id': '2011-A00860-41', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patient with primitive form of IgA nephropathy', 'interventionNames': ['Biological: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'BIOLOGICAL', 'description': 'dosage of anti-hinge region antibodies', 'armGroupLabels': ['patient with primitive form of IgA nephropathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74000', 'city': 'Annecy', 'country': 'France', 'facility': "CH d'ANNECY", 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '07100', 'city': 'Annonay', 'country': 'France', 'facility': "CH d'ANNONAY", 'geoPoint': {'lat': 45.23992, 'lon': 4.6707}}, {'zip': '01000', 'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'CH de BOURG EN BRESSE', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'CH de CHAMBERY', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de CLERMONT-FERRAND', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de DIJON', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de GRENOBLE', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '43000', 'city': 'Le Puy-en-Velay', 'country': 'France', 'facility': 'CH du PUY EN VELAY', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard. HERRIOT', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier de Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '42300', 'city': 'Roanne', 'country': 'France', 'facility': 'CH de ROANNE', 'geoPoint': {'lat': 46.03624, 'lon': 4.06802}}, {'zip': '26100', 'city': 'Romans', 'country': 'France', 'facility': 'Hôpitaux Drome Nord', 'geoPoint': {'lat': 46.1198, 'lon': 5.02486}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de SAINT-ETIENNE', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '26000', 'city': 'Valence', 'country': 'France', 'facility': 'CH de VALENCE', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '69100', 'city': 'Villeurbanne', 'country': 'France', 'facility': 'Clinique du TONKIN', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'overallOfficials': [{'name': 'Christophe MARIAT, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}