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

Amgen

Status and phase

Completed

Phase 4

Conditions

Chronic Kidney Disease

Calcification

Hyperparathyroidism

Chronic Renal Failure

Vascular Calcification

Nephrology

End Stage Renal Disease

Coronary Artery Calcification

Secondary Hyperparathyroidism

Kidney Disease

Cardiovascular Disease

Treatments

Drug: cinacalcet

Study type

Interventional

Funder types

Industry

Identifiers

NCT00379899

20060111

Details and patient eligibility

About

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

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.