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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Cinacalcet; Cinacalcet Hydrochloride; Ergocalciferols; Vitamin D; Vitamins

Criteria

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.