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

Completed · Phase 3

Conditions studied: Hyperparathyroidism, Secondary

In brief

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.

Key facts

Study ID

NCT01785875

Run by

Amgen

People needed

891

Starts

2013-07-31

Expected to finish

2015-07-01

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Pine Bluff, Arkansas, United States
• Research Site — Azusa, California, United States
• Research Site — Bakersfield, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Cudahy, California, United States
• Research Site — Fairfield, California, United States
• Research Site — Glendale, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Lynwood, California, United States
• Research Site — Northridge, California, United States
• Research Site — Norwalk, California, United States
• Research Site — Ontario, California, United States
• Research Site — Riverside, California, United States
• Research Site — San Gabriel, California, United States
• Research Site — Simi Valley, California, United States
• Research Site — Whittier, California, United States
• Research Site — Arvada, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Coral Springs, Florida, United States
• Research Site — Lauderdale Lakes, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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