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Clinical Trial Details

Trial ID: L1337
Source ID: NCT00379899
Associated Drug: Cinacalcet
Title: ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00379899/results
Conditions: Chronic Kidney Disease|End Stage Renal Disease|Coronary Artery Calcification|Vascular Calcification|Calcification|Cardiovascular Disease|Chronic Renal Failure|Hyperparathyroidism|Kidney Disease|Nephrology|Secondary Hyperparathyroidism
Interventions: DRUG: cinacalcet
Outcome Measures: Primary: Percent Change From Baseline in CAC Score, Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification., Baseline and Week 52 | Secondary: Number of Participants Achieving > 15% Progression of CAC., Number of participants achieving \>15% progression of coronary artery calcification (CAC) at week 52, 52 weeks|Absolute Change in PTH, Absolute change from baseline in intact Parathyroid Hormone (iPTH), Baseline and Week 52|Change From Baseline in AC Score, Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to \>75,000, with 0 representing no calcification., Baseline and Week 52|Change From Baseline of the Progression of AVC., Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to \>10,000, with 0 representing no calcification., Baseline and Week 52|Percent Change in PTH, Percent change from baseline in intact Parathyroid Hormone (iPTH), Baseline and Week 52|Absolute Change in Calcium, Absolute change from baseline in serum calcium to weeks 44 through 52, Baseline and Weeks 44 through 52|Percent Change in Calcium, Percent change from baseline in corrected serum calcium to weeks 44 through 52, Baseline and Weeks 44 through 52|Absolute Change in Phosphorus, Absolute change from baseline in serum phosphorus to weeks 44 through 52, Baseline and Weeks 44 through 52|Percent Change in Phosphorus, Percent change from baseline in serum phosphorus to weeks 44 through 52, Baseline and Weeks 44 through 52|Absolute Change in Ca x P, Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52, Baseline and Weeks 44 through 52|Percent Change in Ca x P, Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52, Baseline and Weeks 44 through 52
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 360
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-09
Completion Date: 2009-11
Results First Posted: 2010-10-27
Last Update Posted: 2014-07-23
Locations:
URL: https://clinicaltrials.gov/show/NCT00379899