At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 87 enrolled
Drug / intervention
Etelcalcetide +1 moredrug
Likely dose
Not stated in 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 Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
In Brief
A Phase 2 clinical trial evaluating Etelcalcetide and Placebo for Secondary Hyperparathyroidism. Completed, enrolled 87 participants across 13 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartFeb 2011
Primary CompletionJul 2011
Study CompletionAug 2011
TodayJul 2026
First PostedDec 6, 2010
Enrollment StartFeb 20, 2011
Primary CompletionJul 1, 2011
Study CompletionAug 24, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.6 years ago
Interventions
Etelcalcetidedrug
Administered intravenously (IV) at the end of hemodialysis
Placebodrug
Administered intravenously at the end of hemodialysis