Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperparathyroidism, Secondary

In brief

This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

Key facts

Study ID

NCT01788046

Run by

Amgen

People needed

515

Starts

2013-03-12

Expected to finish

2014-05-09

Last updated by the study team

2019-08-20

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 is 18 years of age or older.
• Subject agrees to not participate in another study of an investigational agent during the study.
• Subject must be receiving hemodialysis 3 times weekly for at least 3 months
• Other Inclusion Criteria may apply

You may not qualify if…

• Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
• Other investigational procedures while participating in this study are excluded.
• Anticipated or scheduled parathyroidectomy during the study period.
• Subject has received a parathyroidectomy within 3 months prior to dosing.
• Anticipated or scheduled kidney transplant during the study period.
• Subject has known sensitivity to any of the products or components to be administered during dosing.
• Subject has participated in a prior clinical trial of AMG 416
• 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.
• Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
• Other Exclusion Criteria may apply

Where it is running

• Research Site — Azusa, California, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Fairfield, California, United States
• Research Site — Glendale, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Northridge, California, United States
• Research Site — Norwalk, California, United States
• Research Site — Riverside, California, United States
• Research Site — Simi Valley, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Lauderdale Lakes, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Macon, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Gurnee, Illinois, United States
• Research Site — Merrillville, Indiana, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Ft. Washington, Maryland, United States
• Research Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.