NCT01896232

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 683 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Secondary Hyperparathyroidism
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Etelcalcetide	Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.
DRUG	Cinacalcet	Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.
DRUG	Oral Placebo	Administered orally once a day.
DRUG	Intravenous Placebo	Administered intravenously (IV) three times per week.

Timeline

• Start date: 2013-08-13
• Primary completion: 2014-11-12
• Completion: 2015-01-08
• First posted: 2013-07-11
• Last updated: 2019-07-18
• Results posted: 2017-02-08

Locations

182 sites across 22 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye)