Back to resultsA Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hectorol (doxercalciferol injection)
Zemplar (Paricalcitol injection)
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Hectorol (doxercalciferol injection), Zemplar (paricalcitol injection)
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Pharmacokinetic Study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00454350
Brief Title
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
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 injection).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Hectorol (doxercalciferol injection), Zemplar (paricalcitol injection)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hectorol (doxercalciferol injection)
Intervention Type
Drug
Intervention Name(s)
Zemplar (Paricalcitol injection)
Primary Outcome Measure Information:
Title
Pharmacokinetic Study
Time Frame
44 hour interval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Minneapolis
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.hectorol.com/docs/Hectorol%20Injection%20PI%20Text_2006-01.pdf
Description
US FDA Approved Full Prescribing Information for Hectorol® Injection
Learn more about this trial
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
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