Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-02 @ 2:16 PM
Study NCT ID:
NCT02237534
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2014-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D061205', 'term': 'Vascular Calcification'}], 'ancestors': [{'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'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Micro RNA array', 'timeFrame': '1 year'}, {'measure': 'Hypercalcemia', 'timeFrame': 'Up to 1 year', 'description': 'Corrected serum calcium concentration ≥11.0 mg/dL'}, {'measure': 'Hypocalcemia', 'timeFrame': 'Up to 1 year', 'description': 'Corrected serum calcium concentration \\<8.5 mg/dL'}], 'primaryOutcomes': [{'measure': 'Coronary artery calcification score', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Endothelial function', 'timeFrame': '3 months', 'description': 'Measured by EndoPAT™ (Itamar Medical Ltd.)'}, {'measure': 'Serum bone metabolic markers', 'timeFrame': '3 months', 'description': 'Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)'}, {'measure': 'Serum bone metabolic markers', 'timeFrame': '1 year', 'description': 'Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)'}, {'measure': 'Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time', 'timeFrame': 'Up to 1 year'}, {'measure': 'Estimated glomerular filtration rate over time', 'timeFrame': 'Up to 1 year'}, {'measure': 'Bone mineral density', 'timeFrame': '1 year'}, {'measure': 'Serum osteoprotegerin concentration', 'timeFrame': '3 month'}, {'measure': 'Serum osteoprotegerin concentration', 'timeFrame': '1 year'}, {'measure': 'Urinary alpha-Klotho to creatinine ratio', 'timeFrame': '3 months'}, {'measure': 'Urinary alpha-Klotho to creatinine ratio', 'timeFrame': '1 year'}, {'measure': 'Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio', 'timeFrame': '3 months'}, {'measure': 'Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio', 'timeFrame': '1 year'}, {'measure': 'End-stage renal disease requiring renal replacement therapy', 'timeFrame': 'Up to 1 year'}, {'measure': 'Cardiovascular event requiring hospitalization', 'timeFrame': 'Up to 1 year', 'description': 'Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease'}, {'measure': 'Death', 'timeFrame': 'Up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lanthanum', 'Calcium Carbonate', 'Vascular Calcification'], 'conditions': ['Renal Insufficiency, Chronic', 'Hyperphosphatemia', 'Bone Diseases, Metabolic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL)\n* With written informed consent\n\nExclusion Criteria:\n\n* History of cardiac surgery\n* With coronary artery stent\n* Polycystic kidney disease\n* Hypothyroidism\n* On treatment with lanthanum carbonate\n* History of admission within 3 months\n* History of ileus\n* Severe liver dysfunction\n* Severe gastrointestinal dysfunction\n* Allergy to lanthanum carbonate or calcium carbonate\n* Pregnant or breastfeeding women\n* Judged as ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT02237534', 'acronym': 'LAVALIER', 'briefTitle': 'Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia', 'organization': {'class': 'OTHER', 'fullName': 'Osaka University'}, 'officialTitle': 'Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia', 'orgStudyIdInfo': {'id': 'CKDR-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium carbonate', 'description': 'Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration \\<4.5 mg/dL. Maximum dose is 3,000 mg/day.', 'interventionNames': ['Drug: Calcium Carbonate']}, {'type': 'EXPERIMENTAL', 'label': 'Lanthanum carbonate', 'description': 'Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration \\<4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day.', 'interventionNames': ['Drug: Lanthanum carbonate']}], 'interventions': [{'name': 'Lanthanum carbonate', 'type': 'DRUG', 'otherNames': ['FOSRENOL®'], 'armGroupLabels': ['Lanthanum carbonate']}, {'name': 'Calcium Carbonate', 'type': 'DRUG', 'armGroupLabels': ['Calcium carbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'overallOfficials': [{'name': 'Takayuki Hamano, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osaka University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Endowed chair', 'investigatorFullName': 'Takayuki Hamano', 'investigatorAffiliation': 'Osaka University'}}}}