The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.
Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.
Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52
Time frame: Baseline to week 40-52
Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)
Number of participants achieving a \>=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
Time frame: Baseline to week 40-52
Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)
Number of participants achieving Plasma PTH \< 300 pg/mL During Efficacy Assessment Phase (EAP)
Time frame: week 40-52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.