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Clinical Trial Details

Trial ID: L1166
Source ID: NCT02237534
Associated Drug: Lanthanum Carbonate
Title: Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
Acronym: LAVALIER
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Renal Insufficiency, Chronic|Hyperphosphatemia|Bone Diseases, Metabolic
Interventions: DRUG: Lanthanum carbonate|DRUG: Calcium Carbonate
Outcome Measures: Primary: Coronary artery calcification score, 1 year | Secondary: Endothelial function, Measured by EndoPAT™ (Itamar Medical Ltd.), 3 months|Serum bone metabolic markers, Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b), 3 months|Serum bone metabolic markers, Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b), 1 year|Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time, Up to 1 year|Estimated glomerular filtration rate over time, Up to 1 year|Bone mineral density, 1 year|Serum osteoprotegerin concentration, 3 month|Serum osteoprotegerin concentration, 1 year|Urinary alpha-Klotho to creatinine ratio, 3 months|Urinary alpha-Klotho to creatinine ratio, 1 year|Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio, 3 months|Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio, 1 year|End-stage renal disease requiring renal replacement therapy, Up to 1 year|Cardiovascular event requiring hospitalization, Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease, Up to 1 year|Death, Up to 1 year | Other: Micro RNA array, 1 year|Hypercalcemia, Corrected serum calcium concentration ≥11.0 mg/dL, Up to 1 year|Hypocalcemia, Corrected serum calcium concentration \<8.5 mg/dL, Up to 1 year
Sponsor/Collaborators: Sponsor: Osaka University | Collaborators: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-09
Completion Date: 2023-09
Results First Posted:
Last Update Posted: 2021-02-25
Locations: Osaka University Hospital, Suita, Osaka, 565-0871, Japan
URL: https://clinicaltrials.gov/show/NCT02237534