ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis

Phase 4

Completed

Conditions: Vascular Calcification
Calcification
Kidney Disease
Nephrology
Chronic Kidney Disease
Coronary Artery Calcification
Cardiovascular Disease
Chronic Renal Failure
End Stage Renal Disease
Secondary Hyperparathyroidism

Interventions: Drug: cinacalcet

Registration Number: NCT00379899

Lead Sponsor: Amgen

Brief Summary: The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with chronic kidney disease receiving hemodialysis

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 360

Inclusion Criteria

Adults with chronic kidney disease receiving hemodialysis.
Lab tests required at screening include Parathyroid Hormone (PTH), calcium, and phosphorus.
A screening coronary artery calcification score of at least 30.

Exclusion Criteria

Subjects on non-calcium or aluminum containing phosphate binders (example: sevelamer HCl, lanthanum) 30 days prior to screening.
Subjects on cinacalcet 30 days prior to screening.
Current or previous use of some osteoporosis medications.
Started or required change in cholesterol lowering medications within 30 days before screening.
Abnormal rhythm of the heart.
Parathyroidectomy done within 3 months prior to screening.
Anticipated parathyroidectomy or kidney transplant.
Current intolerance to oral medications, or inability to swallow.
Unstable medical condition.
Currently enrolled, or fewer than 30 days have passed since subject used another investigational device or drug.
Pregnancy or breast feeding.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	cinacalcet	Standard of care, without use of cinacalcet.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in CAC Score	Baseline and Week 52	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Ca x P	Baseline and Weeks 44 through 52	Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52
Change From Baseline of the Progression of AVC.	Baseline and Week 52	Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to \>10,000, with 0 representing no calcification.
Number of Participants Achieving > 15% Progression of CAC.	52 weeks	Number of participants achieving \>15% progression of coronary artery calcification (CAC) at week 52
Percent Change in PTH	Baseline and Week 52	Percent change from baseline in intact Parathyroid Hormone (iPTH)
Absolute Change in Calcium	Baseline and Weeks 44 through 52	Absolute change from baseline in serum calcium to weeks 44 through 52
Percent Change in Calcium	Baseline and Weeks 44 through 52	Percent change from baseline in corrected serum calcium to weeks 44 through 52
Absolute Change in Ca x P	Baseline and Weeks 44 through 52	Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52
Absolute Change in PTH	Baseline and Week 52	Absolute change from baseline in intact Parathyroid Hormone (iPTH)
Change From Baseline in AC Score	Baseline and Week 52	Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to \>75,000, with 0 representing no calcification.
Absolute Change in Phosphorus	Baseline and Weeks 44 through 52	Absolute change from baseline in serum phosphorus to weeks 44 through 52
Percent Change in Phosphorus	Baseline and Weeks 44 through 52	Percent change from baseline in serum phosphorus to weeks 44 through 52