Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
- Registration Number
- NCT01932970
- Lead Sponsor
- Amgen
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Etelcalcetide Etelcalcetide Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period 4 weeks
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Parathyroid Hormone During the Treatment Period Baseline and weeks 2, 3 and 4 Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period 4 weeks
Trial Locations
- Locations (1)
Research Site
🇺🇸Hampton, Virginia, United States