Secondary Hyperparathyroidism
Conditions
Keywords
Hectorol (doxercalciferol injection), Zemplar (paricalcitol injection)
Brief summary
This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).
Interventions
DRUGHectorol (doxercalciferol injection)
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject must be receiving hemodialysis three times per week for a minimum of three months. * The subject must be receiving intravenous doxercalciferol or paricalcitol at each dialysis session (three times weekly) for a minimum of 12 weeks prior to Screening. * At Screening Visit the subject's laboratory measurements must be within the following ranges: Serum iPTH measurement between 150-800 pg/mL; Corrected calcium measurement ≤ 10.5 mg/dL; Serum phosphorus measurement ≤ 7 mg/dL
Exclusion criteria
* Any ongoing use of over the counter or prescription vitamin D preparations except doxercalciferol or paricalcitol injection or multivitamins. * History of heparin-induced thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Study | 44 hour interval |
Countries
United States
Outcome results
None listed