NCT02102204

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

A Multicenter Single-arm Extension Study to Describe the Long-term 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: 902 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

Detailed description

This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Conditions

• Hyperparathyroidism, Secondary

Interventions

Type	Name	Description
DRUG	Etelcalcetide	Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Timeline

• Start date: 2014-03-25
• Primary completion: 2016-11-04
• Completion: 2017-06-26
• First posted: 2014-04-02
• Last updated: 2017-11-17
• Results posted: 2017-11-17

Locations

228 sites across 24 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye)