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

Amgen

Status and phase: Completed; Phase 3

Conditions: Hyperparathyroidism, Secondary

Treatments: Drug: Etelcalcetide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01785875

2012-002808-41 (EudraCT Number)

20120231

KAI-4169-008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 891 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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891 participants in 1 patient group

Etelcalcetide

Experimental group

Description:

Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Treatment:

Drug: Etelcalcetide