A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection

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.

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.

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.