NCT01785875

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 891 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

Conditions

• Hyperparathyroidism, Secondary

Interventions

Type	Name	Description
DRUG	Etelcalcetide	Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).

Timeline

• Start date: 2013-07-31
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-02-07
• Last updated: 2019-04-10
• Results posted: 2017-03-27

Locations

208 sites across 17 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom