At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 100 enrolled
Drug / intervention
Zemplar (paricalcitol)drug
Likely dose
Zemplar (paricalcitol) 4 mcgfrom 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.
Effectiveness and Safety of a 6-Month Treatment With IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
In Brief
A Phase 4 clinical trial evaluating Zemplar (paricalcitol) for Secondary Hyperparathyroidism and 4 related conditions. Completed, enrolled 100 participants across 3 sites.
Detailed Summary
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism, Renal Insufficiency, Chronic, Parathyroid Hormone, Hemodialysis, Hypercalcemia
CountriesPeru
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartMay 2009
Primary CompletionSep 2010
TodayJul 2026
First PostedMay 1, 2009
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.2 years ago
Interventions
Zemplar (paricalcitol)drug
Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.