Back to resultsA Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hectorol (doxercalciferol capsules)
Zemplar (paricalcitol injection)
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Hectorol (doxercalciferol capsules), Zemplar (paricalcitol injection)
Eligibility Criteria
Inclusion Criteria:
- The subject must be receiving hemodialysis three times per week for a minimum of six months.
- The subject must have been receiving Zemplar Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
- The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL.
Exclusion Criteria:
- In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
- Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
- The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
- Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
Sites / Locations
Outcomes
Primary Outcome Measures
Dose Conversion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00463021
Brief Title
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Official Title
A Phase 4, Multi Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® (Doxercalciferol Capsules) When Converting From Zemplar® (Paricalcitol Injection) for the Treatment of Secondary Hyperparathyroidism in Stage 5 Chronic Kidney Disease (CKD) Subjects on Hemodialysis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Hectorol (doxercalciferol capsules), Zemplar (paricalcitol injection)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hectorol (doxercalciferol capsules)
Intervention Type
Drug
Intervention Name(s)
Zemplar (paricalcitol injection)
Primary Outcome Measure Information:
Title
Dose Conversion
Time Frame
10 weeks
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 six months.
The subject must have been receiving Zemplar Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL.
Exclusion Criteria:
In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
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
Downey
State/Province
California
Country
United States
City
Paramount
State/Province
California
Country
United States
City
Hudson
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Decatur
State/Province
Georgia
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.hectorol.com/docs/Hectorol%20Capsule%20PI%20Text_2006-01.pdf
Description
US FDA Approved Full Prescribing Information for Hectorol® Capsules
Learn more about this trial
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
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