Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism

KAI Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Etelcalcetide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01576146

KAI-4169-005-01

20120334 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject provides written informed consent.
• Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).

Exclusion criteria

• Subject pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Etelcalcetide

Experimental group

Description:

Participants received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.

Treatment:

Drug: Etelcalcetide