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Study Complete
Sponsor ID
20120231

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients with Chronic Kidney Disease (CKD) on Hemodialysis

Sponsor ID
20120231
Clinicaltrials.gov ID
NCT01785875
EUCTIS ID
N/A
EudraCT ID
2012-002808-41
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
AMG 416
Type
Interventional
Masking
None (Open Label)
Enrollment
891
Additional Study Details

Protocol Summary

Primary Outcome Measures

Long-term safety and tolerability of intravenous administration of AMG 416 in hemodialysis subjects with secondary hyperparathyroidism (SHPT) as assessed by the nature, frequency, severity, and relationship to treatment of all reported adverse events.

Timeframe: 52 weeks

Secondary Outcome Measures

Proportion of subjects with >30% reduction from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12)

Timeframe: 52 weeks

Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12)

Timeframe: 52 weeks

Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12)

Timeframe: 52 weeks

Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12)

Timeframe: 52 weeks

Percent change from baseline in predialysis serum cCa x P during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12)

Timeframe: 52 weeks

Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12)

Timeframe: 52 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Arvada, CO, United States, 80002
Status
Recruiting
Location
Research Site
Chattanooga, TN, United States, 37408
Status
Recruiting
Location
Research Site
Azusa, CA, United States, 91702
Status
Recruiting
Location
Research Site
Bakersfield, CA, United States, 93308
Status
Recruiting
Location
Research Site
Barcelona, Cataluña, Spain, 08036
Status
Recruiting
Location
Research Site
Baudour, Belgium, 7331
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    Jul 2013 - Jul 2015
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject understands the study procedures and agrees to participate in the study by giving written informed consent. - Subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970). - Subject agrees to not participate in another study of an investigational agent during the study. - Other Inclusion Criteria may apply
    Exclusion Criteria:
    - Currently receiving treatment in another investigational device or drug study. - Currently receiving other investigational procedures while participating in this study. - Subject has known sensitivity to any of the products or components to be administered during dosing. - Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator. Other Exclusion Criteria may apply