A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Completed · Phase 4
Conditions studied: Secondary Hyperparathyroidism
In brief
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.
Key facts
- Study ID
- NCT00463021
- Run by
- Genzyme, a Sanofi Company
- People needed
- 36
- Starts
- 2007-04-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2015-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Downey, California, United States
- Study site — Paramount, California, United States
- Study site — Hudson, Florida, United States
- Study site — Augusta, Georgia, United States
- Study site — Decatur, Georgia, United States
- Study site — Pittsburgh, Pennsylvania, United States
- Study site — Nashville, Tennessee, United States
- Study site — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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