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

• Status: Completed
• Trial end date: 2014-05-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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 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

Exclusion Criteria:

• 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