NCT01932970

Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hyperparathyroidism, Secondary

Interventions

Type	Name	Description
DRUG	Etelcalcetide	Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.

Timeline

• Start date: 2013-08-12
• Primary completion: 2014-01-14
• Completion: 2017-02-14
• First posted: 2013-08-30
• Last updated: 2018-10-17
• Results posted: 2017-04-04

Locations

40 sites across 1 country: United States