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Study Complete
Sponsor ID
20120359

Study to Assess the Impact on Calcium Levels when Hemodialysis Patients with Secondary Hyperparathyroidism (SHPT) Switch from Cinacalcet to Etelcalcetide

Sponsor ID
20120359
Clinicaltrials.gov ID
NCT01932970
EUCTIS ID
N/A
EudraCT ID
2013-000964-28
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Study Details

This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

Additional Study Details

Phase
Phase 3
Product
AMG 416
Type
Interventional
Masking
None (Open Label)
Enrollment
158
Additional Study Details

Protocol Summary

Primary Outcome Measures

Measure the subject incidence of serum cCa values <7.5 mg/dL during the treatment period following initiation of treatment with AMG 416 5mg IV TIW.

Timeframe: 4 weeks

Secondary Outcome Measures

Percent change from baseline in PTH levels during the treatment period

Timeframe: 4 weeks

Incidence of serum cCa values <8.3 mg/dL during the treatment period

Timeframe: 4 weeks

Assess the nature, frequency, severity, and relationship to treatment of all adverse events

Timeframe: from informed consent to 30 days after treatment

Assess the incidence of symptomatic hypocalcemia during the treatment period

Timeframe: 4 weeks

Study Documents

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

Locations

Location
Status
Contact Us
Location
Research Site
Alhambra, CA, United States, 91801
Status
Recruiting
Location
Research Site
Arlington, TX, United States, 76015
Status
Completed
Location
Research Site
Arvada, CO, United States, 80002
Status
Completed
Location
Research Site
Azusa, CA, United States, 91702
Status
Recruiting
Location
Research Site
Bakersfield, CA, United States, 93308
Status
Completed
Location
Research Site
Baton Rouge, LA, United States, 70808
Status
Completed
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Study Info
Age
18 - 100 Years
Condition
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    Aug 2013 - Jan 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria • Subject is 18 years of age or older at the time of informed consent. • Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks. • Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet. • Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet. • Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening). • Other Inclusion Criteria may apply. Exclusion Criteria • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s). • Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169). • Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing. • Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416. • Subject is pregnant or nursing. • Anticipated or scheduled parathyroidectomy during the study period. • Subject has received a parathyroidectomy within 6 months prior to dosing. • Other Exclusion Criteria may apply.