Overview

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

Status:
Terminated
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
KAI Pharmaceuticals
Criteria
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