A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Information source: Genzyme
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Secondary Hyperparathyroidism
Intervention: Hectorol (doxercalciferol capsules) (Drug); Zemplar (paricalcitol injection) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
Ajay Duggal, M.D., Study Director, Affiliation: Genzyme
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Dose Conversion
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Downey, California, United States
Paramount, California, United States
Hudson, Florida, United States
Decatur, Georgia, United States
Augusta, Georgia, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Norfolk, Virginia, United States
Additional Information
US FDA Approved Full Prescribing Information for Hectorol® Capsules
Starting date: April 2007
Ending date: December 2007
Last updated: December 20, 2007
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