At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 41 enrolled
Drug / intervention
Zemplar® injection +1 moredrug
Likely dose
Zemplar 6 mcg intravenous every other day (QOD) or Hectorol 3.6 mcg intravenous every other day (QOD)AI-extracted
Key inclusion· 7
- ✓Age ≥20 years
- ✓CKD Stage 5 on maintenance hemodialysis 3x/week for ≥2 months prior to screening, expected to continue for study duration
- ✓Intact PTH >200 pg/mL at screening
- ✓Serum calcium <10.2 mg/dL at screening
Key exclusion· 7
- ✕History of allergic reaction or significant sensitivity to vitamin D or vitamin D-related compounds
- ✕Chronic gastrointestinal disease with risk of clinically significant malabsorption
- ✕Liver function defects: liver enzymes >2× upper limit of normal
- ✕Hemoglobin <9.0 g/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Single-Center, Open-Label, Randomized, Active-Controlled, Cross-over Pilot Study to Evaluate the Effects of Two Vitamin D Analogs, Zemplar® Injection and Hectorol® Injection, on Intestinal Absorption of Calcium in CKD Stage 5 Subjects on Hemodialysis
In Brief
A Phase 4 clinical trial evaluating Zemplar® injection and Hectorol® injection for Chronic Kidney Disease, Stage 5 and Secondary Hyperparathyroidism. Completed, enrolled 41 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2005
Enrollment StartJun 2006
Primary CompletionJan 2008
TodayJul 2026
First PostedNov 24, 2005
Enrollment StartJun 1, 2006
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.6 years ago
Interventions
Zemplar® injectiondrug
6 mcg QOD
Hectorol® injectiondrug
3.6 mcg QOD