At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 enrolled
Drug / intervention
Etelcalcetidedrug
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 Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder
In Brief
A Phase 2 clinical trial evaluating Etelcalcetide for Secondary Hyperparathyroidism. Completed, enrolled 37 participants.
Detailed Summary
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartDec 2011
Primary CompletionMay 2012
TodayJul 2026
First PostedAug 11, 2011
Enrollment StartDec 5, 2011
Primary CompletionMay 21, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.9 years ago
Interventions
Etelcalcetidedrug
Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.