Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-29 @ 6:50 PM
Study NCT ID:
NCT01578200
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2012-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}, {'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}, {'id': 'D061205', 'term': 'Vascular Calcification'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002114', 'term': 'Calcinosis'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2309}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-24'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-27', 'studyFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2012-04-13', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular event free survival time.', 'timeFrame': '3 years', 'description': 'Cardiovascular event consisting of\n\n1. death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1),\n2. nonfatal myocardial infarction,\n3. nonfatal cerebral stroke including transient ischemic attack, TIA,\n4. unstable angina,\n5. hospitalization for heart failure,\n6. hospitalization for ventricular arrhythmia'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years'}, {'measure': 'Secondary hyperparathyroidism free survival', 'timeFrame': '3 years'}, {'measure': 'Hip fracture free survival', 'timeFrame': '3 years'}, {'measure': 'Quality of life questionnaire (KDQOL-SF, v1.3)', 'timeFrame': '3 years'}, {'measure': 'Bone mineral density (DEXA)', 'timeFrame': '3 years'}]}, 'conditionsModule': {'keywords': ['CKD-MBD', 'phosphate-binder', 'vascular calcification', 'mortality', 'dialysis', 'Hemodialysis patients with hyperphosphatemia'], 'conditions': ['Hemodialysis', 'Hyperphosphatemia']}, 'referencesModule': {'references': [{'pmid': '40576086', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.'}, {'pmid': '34003226', 'type': 'DERIVED', 'citation': 'Ogata H, Fukagawa M, Hirakata H, Kagimura T, Fukushima M, Akizawa T; LANDMARK Investigators and Committees. Effect of Treating Hyperphosphatemia With Lanthanum Carbonate vs Calcium Carbonate on Cardiovascular Events in Patients With Chronic Kidney Disease Undergoing Hemodialysis: The LANDMARK Randomized Clinical Trial. JAMA. 2021 May 18;325(19):1946-1954. doi: 10.1001/jama.2021.4807.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.', 'detailedDescription': 'Elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. A recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. A post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* hemodialysis patients with hyperphosphatemia who require phosphate binders\n* hemodialysis for more than 3 months\n* patients who have at least one calcification risk factor (elderly \\> 65 years, postmenopausal woman, type 2 diabetes mellitus)\n* intact-PTH \\< or = 240pg/mL\n* life expectancy \\> 1 year\n* with written informed consent\n\nExclusion Criteria:\n\n* contraindications to lanthanum carbonate and calcium carbonate\n* swallowing disorders\n* severe GI disorders\n* history of obstructed bowels\n* history of IHD/stroke within 6 months before randomization\n* NYHA classification Ⅲ-Ⅳ\n* severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution\n* require treatment of arrhythmia\n* severe malnutrition\n* malignancy of any type within the last five years\n* peritoneal dialysis patients\n* pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term\n* ineligible patients according to the investigator's judgment"}, 'identificationModule': {'nctId': 'NCT01578200', 'acronym': 'LANDMARK', 'briefTitle': 'Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study', 'organization': {'class': 'OTHER', 'fullName': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan'}, 'officialTitle': 'Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D)', 'orgStudyIdInfo': {'id': 'TRIGU1111'}, 'secondaryIdInfos': [{'id': 'UMIN000006815', 'type': 'REGISTRY', 'domain': 'UMIN Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lanthanum carbonate', 'description': 'Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg.', 'interventionNames': ['Drug: Lanthanum Carbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium Carbonate', 'description': 'Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g.', 'interventionNames': ['Drug: Calcium Carbonate']}], 'interventions': [{'name': 'Lanthanum Carbonate', 'type': 'DRUG', 'armGroupLabels': ['Lanthanum carbonate']}, {'name': 'Calcium Carbonate', 'type': 'DRUG', 'armGroupLabels': ['Calcium Carbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '142-0064', 'city': 'Shinagawa', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Showa University'}], 'overallOfficials': [{'name': 'Tadao Akizawa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Showa University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Showa University School of Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}