Status:
COMPLETED
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Lead Sponsor:
Amgen
Conditions:
Chronic Kidney Disease
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 fle...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00379899
Start Date
September 1 2006
End Date
November 1 2009
Last Update
July 23 2014
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