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A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis

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ClinicalTrials.gov Identifier: NCT00454350
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : May 5, 2015
Sponsor:
Information provided by:

March 28, 2007
March 30, 2007
May 5, 2015
February 2007
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Pharmacokinetic Study [ Time Frame: 44 hour interval ]
Pharmacokinetic Study
Complete list of historical versions of study NCT00454350 on ClinicalTrials.gov Archive Site
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A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
A Randomized , Open-Label, Cross-over, Pharmacokinetic Study of Doxercalciferol and Paricalcitol Following Multiple Intravenous Injections in Chronic Kidney Disease Subjects on Hemodialysis
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Secondary Hyperparathyroidism
  • Drug: Hectorol (doxercalciferol injection)
  • Drug: Zemplar (Paricalcitol injection)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00454350
HECT00106
Not Provided
Not Provided
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP