Back to resultsA Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hectorol® (doxercalciferol capsules)
doxercalciferol capsules, Hectorol®
doxercalciferol capsules, Hectorol® capsules
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Secondary Hyperparathyroidism, Hectorol® (doxercalciferol capsules), Hectorol® (doxercalciferol 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 Hectorol 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.
- Current use of aluminum or magnesium based binders.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
1
2
3
Arm Description
Hectorol capsules at 1.0 times current injection dose
Hectorol capsules at 1.5 times current injection dose
Hectorol capsules at 2.0 times current injection dose
Outcomes
Primary Outcome Measures
Dose Conversion
Secondary Outcome Measures
Full Information
NCT ID
NCT00418600
First Posted
January 3, 2007
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00418600
Brief Title
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Official Title
A Phase 4, Multi-Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® Capsules When Converting From Hectorol® Injection for the Treatment of SHPT in Stage 5 CKD Subjects on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Secondary Hyperparathyroidism, Hectorol® (doxercalciferol capsules), Hectorol® (doxercalciferol injection)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Hectorol capsules at 1.0 times current injection dose
Arm Title
2
Arm Type
Other
Arm Description
Hectorol capsules at 1.5 times current injection dose
Arm Title
3
Arm Type
Other
Arm Description
Hectorol capsules at 2.0 times current injection dose
Intervention Type
Drug
Intervention Name(s)
Hectorol® (doxercalciferol capsules)
Intervention Description
Hectorol capsules at 1.0 times current injection dose
Intervention Type
Drug
Intervention Name(s)
doxercalciferol capsules, Hectorol®
Intervention Description
Hectorol capsules at 1.5 times current injection dose
Intervention Type
Drug
Intervention Name(s)
doxercalciferol capsules, Hectorol® capsules
Intervention Description
Hectorol capsules at 2.0 times current injection dose
Primary Outcome Measure Information:
Title
Dose Conversion
Time Frame
5 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 Hectorol 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.
Current use of aluminum or magnesium based binders.
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
Hot Springs
State/Province
Arkansas
Country
United States
City
Downey
State/Province
California
Country
United States
City
Tarzana
State/Province
California
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Spokane
State/Province
Washington
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
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, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
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