At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 255 enrolled
Drug / intervention
paricalcitol +3 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.
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
In Brief
A Phase 3 clinical trial evaluating paricalcitol, maxacalcitol, and 2 other interventions for Secondary Hyperparathyroidism and Hemodialysis. Completed, enrolled 255 participants across 45 sites.
Detailed Summary
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism, Hemodialysis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartMay 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedApr 26, 2011
Enrollment StartMay 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.2 years ago
Interventions
paricalcitoldrug
maxacalcitoldrug
paricalcitol placebodrug
maxacalcitol placebodrug