Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT01187628
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2010-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Study in Chronic Kidney Disease (Extension From Study 14817)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119467', 'term': 'lanthanum carbonate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2010-08-23', 'studyFirstSubmitQcDate': '2010-08-23', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events', 'timeFrame': 'baseline to Week 60'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Long-term study in Chronic Kidney Disease', 'Lanthanum Carbonate'], 'conditions': ['Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).\n\nExclusion Criteria:\n\n* Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study'}, 'identificationModule': {'nctId': 'NCT01187628', 'briefTitle': 'Long-term Study in Chronic Kidney Disease (Extension From Study 14817)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)', 'orgStudyIdInfo': {'id': '15074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)']}], 'interventions': [{'name': 'Fosrenol (Lanthanum Carbonate, BAY77-1931)', 'type': 'DRUG', 'description': 'Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '446-8602', 'city': 'Anjo', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.95828, 'lon': 137.08054}}, {'zip': '455-8530', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '457-8510', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '460-0001', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466-8650', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '489-8642', 'city': 'Seto', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.23333, 'lon': 137.1}}, {'zip': '441-8021', 'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'zip': '498-8502', 'city': 'Yatomi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.1053, 'lon': 136.73378}}, {'zip': '296-0041', 'city': 'Kamogawa', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.0969, 'lon': 140.1003}}, {'zip': '292-8535', 'city': 'Kisarazu', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.38329, 'lon': 139.93254}}, {'zip': '810-8563', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '814-0180', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 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'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '234-8503', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '612-8555', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '874-0011', 'city': 'Beppu', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 33.27945, 'lon': 131.49751}}, {'zip': '870-0263', 'city': 'Ōita', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'zip': '710-8602', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '700-0013', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '530-0012', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '530-8480', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '534-0021', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '558-8558', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '591-8025', 'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'zip': '840-0054', 'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '421-0193', 'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '770-0011', 'city': 'Tokushima', 'state': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '136-0075', 'city': 'Koto', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '152-8902', 'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '105-8471', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '180-8610', 'city': 'Musashino', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.70611, 'lon': 139.55944}}, {'zip': '141-8625', 'city': 'Shinagawa', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '641-8510', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shire', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}