Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:51 AM
Study NCT ID:
NCT00858260
Status:
COMPLETED
Last Update Posted:
2009-09-04
First Post:
2009-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arnogene: A Phosphocalcic Study in Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Searching for high morbi-mortality risk Klotho variants'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-03', 'studyFirstSubmitDate': '2009-03-06', 'studyFirstSubmitQcDate': '2009-03-06', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing morbi-mortality based on Klotho variants'}], 'secondaryOutcomes': [{'measure': 'Survival and serum phosphocalcic parameters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Klotho', 'calcium', 'phosphate', 'parathormone', 'survival', 'dialysis', 'Adult patients undergoing maintenance dialysis since at leat three months'], 'conditions': ['Dialysis']}, 'referencesModule': {'references': [{'pmid': '28402487', 'type': 'DERIVED', 'citation': 'Marcais C, Maucort-Boulch D, Drai J, Dantony E, Carlier MC, Blond E, Genet L, Kuentz F, Lataillade D, Legrand E, Moreau-Gaudry X, Jean G, Fouque D; ARNOGENE Project. Circulating Klotho Associates With Cardiovascular Morbidity and Mortality During Hemodialysis. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3154-3161. doi: 10.1210/jc.2017-00104.'}]}, 'descriptionModule': {'briefSummary': 'Searching for high morbi-mortality risk Klotho variants in dialysis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing maintenance dialysis since at leat three months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every adult \\> 18 years old and treated by dialysis in centers located in the Rhone Alpes area in France.'}, 'identificationModule': {'nctId': 'NCT00858260', 'acronym': 'ARNOGENE', 'briefTitle': 'Arnogene: A Phosphocalcic Study in Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Genetic Determinants of Phosphocalcic Metabolism in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '2007.471/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hemodialysis patients', 'description': 'Adult patients undergoing maintenance dialysis since at leat three months', 'interventionNames': ['Genetic: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'GENETIC', 'description': 'Searching for Klotho variants in DNA', 'armGroupLabels': ['hemodialysis patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'FOUQUE Denis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'LEGRAND Eric, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Annonay'}, {'name': 'KAARASLAN Huseyin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Bourgoin Jallieu'}, {'name': 'ABOKASEM Ayman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Chalon/saône'}, {'name': 'LATAILLADE Claire Dominique, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Sallanches'}, {'name': 'KUENTZ François, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Dialyse eaux claires'}, {'name': 'HACHACHE Toufic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Grenoble - La Tronche'}, {'name': 'LEITIENNE Philippe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'ARKOUCHE Walid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AURAL - Lyon'}, {'name': 'HEYANI Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH MACON'}, {'name': 'HANNOUN Jacques, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Villefranche/saône'}, {'name': 'COMBARNOUS François, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique du Tonkin VILLEURBANNE'}, {'name': 'MAUREAUGANDRY Xavier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AGDUC - Montélimar'}, {'name': 'SIRAJEDINE Mohamed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH ROMANS/ISERE'}, {'name': 'JEAN Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre du Rein - Tassin la demi lune'}, {'name': 'DENICOLA Cora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Calydial - CH Viennes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pr Denis FOUQUE', 'oldOrganization': 'Hospices Civils de Lyon'}}}}