NCT01254565

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (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 and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).

Conditions

• Secondary Hyperparathyroidism

Interventions

Type	Name	Description
DRUG	Etelcalcetide	Administered intravenously (IV) at the end of hemodialysis
DRUG	Placebo	Administered intravenously at the end of hemodialysis

Timeline

• Start date: 2011-02-20
• Primary completion: 2011-07-01
• Completion: 2011-08-24
• First posted: 2010-12-06
• Last updated: 2017-04-13
• Results posted: 2017-04-13

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study