Status:
COMPLETED
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 injec...
Eligibility Criteria
Inclusion
- 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
- Any ongoing use of over the counter or prescription vitamin D preparations except doxercalciferol or paricalcitol injection or multivitamins.
- History of heparin-induced thrombocytopenia.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00454350
Start Date
February 1 2007
End Date
July 1 2007
Last Update
May 5 2015
Active Locations (1)
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1
Minneapolis, Minnesota, United States