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Study Complete
Sponsor ID
20120230

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

Sponsor ID
20120230
Clinicaltrials.gov ID
NCT01788046
EUCTIS ID
N/A
EudraCT ID
2012-002806-31
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
AMG 416
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
515
Additional Study Details

Protocol Summary

Primary Outcome Measures

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.

Timeframe: 27 weeks

Secondary Outcome Measures

Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase

Timeframe: 27 weeks

Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase

Timeframe: 27 weeks

Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase

Timeframe: 27 weeks

Percent change from baseline in predialysis cCa x P during the Efficacy Assessment Phase

Timeframe: 27 weeks

Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase

Timeframe: 27 weeks

Study Documents

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

Locations

Location
Status
Contact Us
Location
Research Site
Chattanooga, TN, United States, 37408
Status
Recruiting
Location
Research Site
Azusa, CA, United States, 91702
Status
Recruiting
Location
Research Site
Denver, CO, United States, 80230
Status
Recruiting
Location
Research Site
Glendale, CA, United States, 91205
Status
Recruiting
Location
Research Site
Lecco, Italy, 23900
Status
Recruiting
Location
Research Site
Macon, GA, United States, 31217
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    Mar 2013 - Apr 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject understands the study procedures and agrees to participate in the study by giving written informed consent. - Subject is 18 years of age or older. - Subject agrees to not participate in another study of an investigational agent during the study. - Subject must be receiving hemodialysis 3 times weekly for at least 3 months - Other Inclusion Criteria may apply
    Exclusion Criteria:
    - Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening. - Other investigational procedures while participating in this study are excluded. - Anticipated or scheduled parathyroidectomy during the study period. - Subject has received a parathyroidectomy within 3 months prior to dosing. - Anticipated or scheduled kidney transplant during the study period. - Subject has known sensitivity to any of the products or components to be administered during dosing. - Subject has participated in a prior clinical trial of AMG 416 - 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. - Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject. - Other Exclusion Criteria may apply