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

A Randomized Study to Evaluate the Effects of Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease (CKD) Receiving Hemodialysis

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

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.