A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
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)
Phase: Phase 4
Status: Completed
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
Ajay Duggal, M.D., Study Director, Affiliation: Genzyme
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.
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 Hectorol® (Doxercalciferol 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 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.
Locations and Contacts
Hot Springs, Arkansas, United States
Downey, California, United States
Tarzana, California, United States
Atlanta, Georgia, United States
Cincinnati, Ohio, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Spokane, Washington, United States
Additional Information
US FDA Approved Full Prescribing Information for Hectorol® Capsules US FDA Approved Full Prescribing Information for Hectorol® Injection
Starting date: November 2006
Ending date: July 2007
Last updated: December 14, 2007
|
