Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

Summary

The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).

Timeline

Start

2011-02-20

Primary completion

2011-07

Completion

2011-08-24

Outcome

Met primary endpoint

registry analysis (superiority test); Cohort 2: Placebo vs Cohort 2: Etelcalcetide 10 mg; p <0.0001; LS Mean Difference -76.9 (95% CI -86.9 to -50.0); ANOVA NCT01254565 ↗

registry analysis (superiority test); Cohort 3: Placebo vs Cohort 3: Etelcalcetide 5 mg; p = 0.0032; LS Mean Difference -36.7 (95% CI -59.8 to -13.6); ANOVA NCT01254565 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etelcalcetide	Other / unclassified	5 mg	Intravenous
Subject	Etelcalcetide	Other / unclassified	10 mg	Intravenous
Subject	Etelcalcetide	Other / unclassified	20 mg	Intravenous

Indications