Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01514851
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2012-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119467', 'term': 'lanthanum carbonate'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-07', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-18', 'lastUpdatePostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period', 'timeFrame': 'baseline to week 8'}, {'measure': 'Presence/absence of incidence of hypercalcemia up to 8 weeks', 'timeFrame': 'up to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of participants achieving target PSPL and time to achievement', 'timeFrame': 'up to 8 weeks'}, {'measure': 'Serum calcium x phosphate product at the end of the double-blind treatment period', 'timeFrame': 'Week 8'}, {'measure': 'Serum intact-PTH (Parathyroid) levels', 'timeFrame': 'Week 8'}, {'measure': 'Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period', 'timeFrame': 'Week 8'}, {'measure': 'Number of participants achieving the target serum calcium levels', 'timeFrame': 'Week 8'}, {'measure': 'Safety variables will be summarized using descriptive statistics based on adverse events collection', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis'], 'conditions': ['Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': 'To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and \\<11.0 mg/dL at 1 week after the initiation of the washout period.\n* Out-patient\n* Undergoing hemodialysis three times per week for at least previous 3 consecutive months\n\nExclusion Criteria:\n\n* Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after\n* Corrected serum calcium level of \\<7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after\n* Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period\n* Pregnant woman, or lactating mother\n* Significant gastrointestinal disorders including known acute peptic ulcer\n* Liver dysfunction\n* History of cardiovascular or cerebrovascular diseases\n* Requiring treatment for hypothyroidism'}, 'identificationModule': {'nctId': 'NCT01514851', 'briefTitle': 'Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': '11877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': '750-2250mg/day, tid (three times a day), 8 weeks', 'interventionNames': ['Drug: Lanthanum carbonate (BAY77-1931)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': '1500-4500mg/day, tid, 8 weeks', 'interventionNames': ['Drug: Calcium carbonate']}], 'interventions': [{'name': 'Lanthanum carbonate (BAY77-1931)', 'type': 'DRUG', 'armGroupLabels': ['Arm 1']}, {'name': 'Calcium carbonate', 'type': 'DRUG', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '441-8023', 'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'zip': '498-0006', 'city': 'Yatomi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.1053, 'lon': 136.73378}}, {'zip': '289-2511', 'city': 'Asahi', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.71667, 'lon': 140.65}}, {'zip': '261-0011', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '277-0084', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '271-0077', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '286-0041', 'city': 'Narita', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.78333, 'lon': 140.31667}}, {'zip': '830-8522', 'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '830-8543', 'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '379-2211', 'city': 'Isesaki', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.31667, 'lon': 139.2}}, {'zip': '730-0811', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '658-0084', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '310-0844', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '300-0053', 'city': 'Tsuchiura', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'zip': '761-8024', 'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'zip': '780-0066', 'city': 'Kochi', 'state': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '989-6117', 'city': 'Ōsaki', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.58866, 'lon': 140.973}}, {'zip': '981-0912', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '701-0202', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '564-0053', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '330-0854', 'city': 'Saitama', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '330-0856', 'city': 'Saitama', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '337-0043', 'city': 'Saitama', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '417-0056', 'city': 'Fuji', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 35.16667, 'lon': 138.68333}}, {'zip': '430-0903', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '770-0011', 'city': 'Tokushima', 'state': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '116-0003', 'city': 'Arakawa-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '187-0001', 'city': 'Kodaira', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}, {'zip': '176-0023', 'city': 'Nerima-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '151-0053', 'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '160-0023', 'city': 'Shinjyuku-ku', 'state': 'Tokyo', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Head Medical Development Japan', 'oldOrganization': 'Bayer Yakuhin Ltd.'}}}}