NCT01134562

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

A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability of Single Ascending Doses of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: KAI Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.

Conditions

• Hyperparathyroidism, Secondary

Interventions

Type	Name	Description
DRUG	Placebo	Single IV injection.
DRUG	Etelcalcetide	Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.

Timeline

• Start date: 2010-09-07
• Primary completion: 2011-04-02
• Completion: 2011-04-02
• First posted: 2010-06-02
• Last updated: 2018-01-02
• Results posted: 2018-01-02

Locations

5 sites across 2 countries: United States, Australia