A Randomized , Open-Label, Cross-over, Pharmacokinetic Study of Doxercalciferol and Paricalcitol Following Multiple Intravenous Injections in Chronic Kidney Disease Subjects on Hemodialysis
| Registry | NCT00454350 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 12 (Estimated) |
| Sponsor | Genzyme, a Sanofi Company (Industry) |
| Conditions | Secondary Hyperparathyroidism |
| Interventions | Hectorol (doxercalciferol injection), Zemplar (Paricalcitol injection) (Drug) |
| Dates | start 2007-02-01, completion 2007-07-01, first posted 2007-03-30, last updated 2015-05-05 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Secondary Hyperparathyroidism All trials of Hectorol (doxercalciferol injection) All trials of Zemplar (Paricalcitol injection)
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).
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Minneapolis, Minnesota | United States |