Assess Impact on Calcium Levels When Hemodialysis Subjects With SHPT Switch From Cinacalcet HCl to AMG 416
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching subjects from cinacalcet to AMG 416.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416|
- 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 ] [ Designated as safety issue: Yes ]
- Percent change from baseline in PTH levels during the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Incidence of serum cCa values <8.3 mg/dL during the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Assess the nature, frequency, severity, and relationship to treatment of all adverse events [ Time Frame: from informed consent to 30 days after treatment ] [ Designated as safety issue: Yes ]
- Assess the incidence of symptomatic hypocalcemia during the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2013|
|Study Completion Date:||April 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: AMG 416
AMG 416 is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Drug: AMG 416
Subjects will be administered IV AMG 416 at the end of their regularly scheduled hemodialysis sessions, for a total of 4 weeks.
Other Name: KAI 4169
This is a multicenter, multiple-dose, single-arm study in which subjects with secondary hyperparathyroidism currently receiving hemodialysis will be switched from oral cinacalcet HCl to intravenous AMG 416.
The study will estimate the subject incidence of serum corrected calcium (cCa) values < 7.5 mg/dL during the 4-week treatment period after initiating of AMG 416 three times per week (TIW) with hemodialysis, 7 days following the discontinuation of daily oral cinacalcet.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01932970
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