Status:
COMPLETED
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 hyperparathyroidis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00418600
Start Date
November 1 2006
End Date
August 1 2007
Last Update
March 19 2015
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Hot Springs, Arkansas, United States
2
Downey, California, United States
3
Tarzana, California, United States
4
Atlanta, Georgia, United States