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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Subject understands the study procedures and agrees to participate in the study by giving written informed consent.

• Subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).

• Subject agrees to not participate in another study of an investigational agent during the study.

• Other Inclusion Criteria may apply

Exclusion Criteria:

• Currently receiving treatment in another investigational device or drug study.

• Currently receiving other investigational procedures while participating in this study.

• Subject has known sensitivity to any of the products or components to be administered during dosing.

• Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.

Other Exclusion Criteria may apply