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

Recruiting in Palo Alto (17 mi)

+103 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Principal Investigator

Amgen

Eligibility 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.

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Treatment Details

Interventions

Etelcalcetide (Calcimimetic Agent)
Placebo (Drug)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EtelcalcetideExperimental Treatment1 Intervention

Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.

Etelcalcetide is already approved in Japan for the following indications: