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Cinacalcet for Vascular Calcification in CKD (ADVANCE)
NCT00379899Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2006
- Primary completion
- May 2009
- Sponsor
- Amgen
- Modality
- Small Molecules
- Drugs
- cinacalcet
- Conditions
- secondary hyperparathyroidism (SHPT)
01
Overview
Phase 4, randomised, open-label trial of cinacalcet in secondary hyperparathyroidism (SHPT) (2 arms), sponsored by Amgen. Primary endpoint: Percent Change From Baseline in Coronary Artery Calcification Score at 52 weeks. Started Sep 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Cinacalcet + Low Dose Vitamin D
Cinacalcet (30-180 mg/day) plus low-dose active vitamin D.
Flexible Vitamin D
Flexible dosing of active vitamin D alone (Standard of Care).
03
Who it enrols
Adults with CKD on hemodialysis with secondary hyperparathyroidism (PTH > 300 pg/mL or 150-300 pg/mL with Ca x P > 50) and a screening coronary artery calcification (CAC) score of at least 30. Patients must not have used cinacalcet or non-calcium/aluminum phosphate binders (e.g., sevelamer) within 30 days.
04
Endpoints
Primary
Percent Change From Baseline in Coronary Artery Calcification Score
Secondary
Number of Participants Achieving > 15% Progression of CAC
Absolute Change in Parathyroid Hormone
Change From Baseline in Aortic Calcification Score
Change From Baseline of the Progression of Aortic Valve Calcification
Absolute and Percent Change in Calcium
Absolute and Percent Change in Phosphorus
Absolute and Percent Change in Calcium-Phosphorus Product
05
Results
Not all primary endpoints met
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