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

Amgen360 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

360

Conditions

Chronic Kidney Disease End Stage Renal Disease Coronary Artery Calcification Vascular Calcification Calcification Cardiovascular Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 52

Secondary Outcomes

Number of Participants Achieving > 15% Progression of CAC.

Number of participants achieving \>15% progression of coronary artery calcification (CAC) at week 52

Time frame: 52 weeks

Absolute Change in PTH

Absolute change from baseline in intact Parathyroid Hormone (iPTH)

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Week 52

Percent Change in PTH

Percent change from baseline in intact Parathyroid Hormone (iPTH)

Time frame: Baseline and Week 52

Absolute Change in Calcium

Absolute change from baseline in serum calcium to weeks 44 through 52