Clinical Trial: Extension Study of Etelcalcetide 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 Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chroni

Brief Summary: This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome:

• Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose until 30 days after last dose; the treatment period was 52 weeks. ]
  Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
• Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 [ Time Frame: 52 weeks ]
  Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.
• Number of Participants Who Developed Anti-etelcalcetide Antibodies [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit ]
  A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.
• Change From Baseline in Blood Pressure [ Time Frame: Baseline and Weeks 24 and 48 ]
• Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment) ]
  The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.
• Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
  The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.
• Percentage of Participants With PTH ≤ 300 pg/mL During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
• Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12 [ Time Frame: Week 46 to 53 ]
• Percent Change From Baseline in Mean PTH During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
• Percent Change From Baseline in Mean PTH During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
• Percent Change From Baseline in Mean Corrected Calcium During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
• Percent Change From Baseline in Mean Corrected Calcium During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
• Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
• Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
• Percent Change From Baseline in Mean Phosphorus During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
• Percent Change From Baseline in Mean Phosphorus During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]

Original Secondary Outcome:

• Proportion of subjects with >30% reduction from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
• Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
• Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
• Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
• Percent change from baseline in predialysis serum cCa x P during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
• Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
• Percentage of subjects whose cCa fall into each of the following categories (<8.3 - 7.5 mg/dL; <7.5 - 7.0 mg/dL; <7.0 mg/dL) [ Time Frame: One year ]

Dates:
Date Received: February 5, 2013
Date Started: July 2013
Date Completion:
Last Updated: February 7, 2017
Last Verified: August 2016