CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 683 enrolled
Drug / intervention
Etelcalcetide +3 moredrug
Likely dose
Etelcalcetide 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01896232
NCT01896232Phase 3Completed
CompareCT.gov

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

Amgen·interventional·Posted Jul 11, 2013·Updated Jul 18, 2019

In Brief

A Phase 3 clinical trial evaluating Etelcalcetide, Cinacalcet, and 2 other interventions for Secondary Hyperparathyroidism and Chronic Kidney Disease. Completed, enrolled 683 participants across 182 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism, Chronic Kidney Disease
CountriesAustria, Belgium, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 11, 2013
Enrollment StartAug 13, 2013
Primary CompletionNov 12, 2014
Study CompletionJan 8, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.0 years ago

Interventions

Etelcalcetidedrug

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.

Cinacalcetdrug

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.

Oral Placebodrug

Administered orally once a day.

Intravenous Placebodrug

Administered intravenously (IV) three times per week.