Study Complete
Sponsor ID
20120360
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Study Details
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Protocol Summary
Primary Outcome Measures
Reduction in mean pre-dialysis serum PTH level
Timeframe: Weeks 20-27
Secondary Outcome Measures
Reduction in mean pre-dialysis serum PTH
Timeframe: Weeks 20-27
Reduction in mean pre-dialysis serum PTH
Timeframe: Weeks 20-27
Frequency of nausea and vomiting
Timeframe: in the first 8 weeks
Change in mean pre-dialysis serum cCA
Timeframe: Weeks 20-27
Pre-dialysis serum phosphorus
Timeframe: Weeks 20-27
Severity of nausea
Timeframe: in the first 8 weeks
Vomiting
Timeframe: in the first 8 weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Almada, Portugal, 2800-455
Status
Recruiting
Location
Research Site
Aveiro, Portugal, 3800-266
Status
Recruiting
Location
Research Site
Burlington, VT, United States, 05401
Status
Recruiting
Location
Research Site
Columbus, MS, United States, 39705
Status
Recruiting
Location
Research Site
Columbus, OH, United States, 43215
Status
Recruiting
Location
Research Site
Estoril, Portugal, 2765-294
Status
Recruiting
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