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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet Versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Amon

Brief 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.

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome: Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to week 40-52 ]

Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52


Original Primary Outcome: To demonstrate the efficacy of treatment with cinacalcet compared to traditional vitamin D therapy, given orally or intravenously (IV), for controlling plasma parathyroid hormone(PTH) levels among hemodialysis subjects with secondary hyperparathyroidism [ Time Frame: 1 year ]

Current Secondary Outcome:

  • Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to week 40-52 ]
    Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
  • Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) [ Time Frame: week 40-52 ]
    Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)


Original Secondary Outcome: To demonstrate a clinically meaningful reduction in plasma parathyroid hormone levels after 1 year of treatment with cinacalcet compared with traditional vitamin D therapy [ Time Frame: 1 year ]

Information By: Amgen

Dates:
Date Received: August 12, 2010
Date Started: October 2010
Date Completion:
Last Updated: February 7, 2017
Last Verified: February 2017