At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 enrolled
Drug / intervention
Paricalcitoldrug
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.
Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
In Brief
A Phase 2 clinical trial evaluating Paricalcitol for Secondary Hyperparathyroidism and Hemodialysis. Completed, enrolled 107 participants across 12 sites.
Detailed Summary
The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism, Hemodialysis
CountriesJapan
CollaboratorsAbbott Japan Co.,Ltd
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2008
Enrollment StartJul 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedJun 19, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.0 years ago
Interventions
Paricalcitoldrug
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.