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Study Complete
Sponsor ID
20120229

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

Sponsor ID
20120229
Clinicaltrials.gov ID
NCT01785849
EUCTIS ID
N/A
EudraCT ID
2012-002805-23
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
AMG 416
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
508
Additional Study Details

Protocol Summary

Primary Outcome Measures

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
Aalst, Belgium, 9300
Status
Recruiting
Location
Research Site
Allentown, PA, United States, 18104
Status
Recruiting
Location
Research Site
Amherst, NY, United States, 14226
Status
Recruiting
Location
Research Site
Ashkelon, Israel, 78278
Status
Recruiting
Location
Research Site
Austin, TX, United States, 78758
Status
Recruiting
Location
Research Site
Azusa, CA, United States, 91702
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    Mar 2013 - May 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 must be receiving hemodialysis 3 times weekly for at least 3 months • 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, 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 (also referred to as KAI-4169). • Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study). • 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