drugset / Trial / NCT01576146

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

NCT01576146

Phase 2 Terminated 30 enrolled KAI Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2012-03
Primary completion
2014-05-01
Completion
2014-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Etelcalcetide Other / unclassified 15 mg Intravenous