Clinical Trial: Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease 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 compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome: Percentage of Participants With a > 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: 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 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 5, 2013
Date Started: March 2013
Date Completion:
Last Updated: February 7, 2017
Last Verified: May 2016