NCT01181531

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet Versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Among Subjects Undergoing Hemodialysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hyperparathyroidism, Secondary

Interventions

Type	Name	Description
DRUG	Traditional Vitamin D Therapy	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.
DRUG	Cinacalcet	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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-07-17
• Completion: 2012-08-14
• First posted: 2010-08-13
• Last updated: 2018-10-17
• Results posted: 2014-04-25