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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which etelcalcetide modulates calcium-sensing receptors in secondary hyperparathyroidism?
How does intravenous etelcalcetide compare to oral cinacalcet in managing serum calcium levels in hemodialysis patients with SHPT?
Which biomarkers are associated with response to calcimimetic therapy in secondary hyperparathyroidism patients undergoing dialysis?
What adverse events are reported when switching hemodialysis patients from cinacalcet to etelcalcetide and how are they managed?
Are there combination therapies involving etelcalcetide that improve outcomes in secondary hyperparathyroidism compared to monotherapy?
Trial Locations
- Locations (1)
Research Site
🇺🇸Hampton, Virginia, United States
Research Site🇺🇸Hampton, Virginia, United States