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

Amgen

Status and phase: Completed; Phase 3

Conditions: Hyperparathyroidism, Secondary

Treatments: Drug: Placebo; Drug: Etelcalcetide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01785849

20120229

KAI-4169-006 (Other Identifier)

2012-002805-23 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 508 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 is 18 years of age or older.
• Subject must be receiving hemodialysis 3 times weekly for at least 3 months
• 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, 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 (also referred to as KAI-4169).
• Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).
• 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: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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508 participants in 2 patient groups, including a placebo group

Etelcalcetide

Experimental group

Description:

Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks.

Treatment:

Drug: Etelcalcetide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo