Clinical Trial: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

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

Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects Wi

Brief Summary: This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome: Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). ]

Participants who did not have any scheduled assessments during the EAP were considered non-responders.


Original Primary Outcome: The proportion of subjects with >30% reduction from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) which is defined as the period between Week 20 and Week 27. [ Time Frame: One year ]

Current Secondary Outcome:

  • Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]
    Participants who had no scheduled assessments during the EAP were considered non-responders.
  • Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase [ Time Frame: Baseline and the Efficacy Assessment Phase (Week 20 to Week 27) ]
  • Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]
  • Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]
  • Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]


Original Secondary Outcome:

  • Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Percent change from baseline in predialysis cCa x P during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Number of subjects with adverse events [ Time Frame: one year ]


Information By: Amgen

Dates:
Date Received: February 7, 2013
Date Started: March 2013
Date Completion:
Last Updated: February 7, 2017
Last Verified: August 2016