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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00454350
First received: March 28, 2007
Last updated: May 4, 2015
Last verified: May 2015

March 28, 2007
May 4, 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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00454350
HECT00106
Not Provided
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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