At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Etelcalcetide 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Placebo and Etelcalcetide for Hyperparathyroidism, Secondary. Completed, enrolled 28 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperparathyroidism, Secondary
CountriesAustralia, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartSep 2010
Primary CompletionApr 2011
TodayJul 2026
First PostedJun 2, 2010
Enrollment StartSep 7, 2010
Primary CompletionApr 2, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.1 years ago
Interventions
Placebodrug
Single IV injection.
Etelcalcetidedrug
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.