A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
Information source: Genzyme
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Secondary Hyperparathyroidism
Intervention: Hectorol (doxercalciferol injection) (Drug); Zemplar (Paricalcitol injection) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
Ajay Duggal, M.D., Study Director, Affiliation: Genzyme
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).
Clinical Details
Official title: A Randomized , Open-Label, Cross-Over, Pharmacokinetic Study of Doxercalciferol and Paricalcitol Following Multiple Intravenous Injections in Chronic Kidney Disease Subjects on Hemodialysis
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Minneapolis, Minnesota, United States
Additional Information
US FDA Approved Full Prescribing Information for Hectorol® Injection
Starting date: February 2007
Ending date: July 2007
Last updated: December 21, 2007
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