Clinical Trial: Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
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 Summary:
Sponsor: Amgen
Current Primary Outcome: Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period [ Time Frame: 4 weeks ]
Original Primary Outcome: 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. [ Time Frame: 4 weeks ]
Current Secondary Outcome:
- Percent Change From Baseline in Parathyroid Hormone During the Treatment Period [ Time Frame: Baseline and weeks 2, 3 and 4 ]
- Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period [ Time Frame: 4 weeks ]
Original Secondary Outcome:
- Percent change from baseline in PTH levels during the treatment period [ Time Frame: 4 weeks ]
- Incidence of serum cCa values <8.3 mg/dL during the treatment period [ Time Frame: 4 weeks ]
- Assess the nature, frequency, severity, and relationship to treatment of all adverse events [ Time Frame: from informed consent to 30 days after treatment ]
- Assess the incidence of symptomatic hypocalcemia during the treatment period [ Time Frame: 4 weeks ]
Information By: Amgen
Dates:
Date Received: August 28, 2013
Date Started: August 2013
Date Completion:
Last Updated: April 12, 2017
Last Verified: April 2017
