A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis

Inclusion Criteria:

• The subject must be receiving hemodialysis three times per week for a minimum of sixmonths.

• The subject must have been receiving Hectorol Injection for a minimum of 3 months. Thesubject must have been on a stable dose regimen, three times per week administrationfor a minimum of four weeks.

• The central laboratory assessment must be within the following ranges: serum iPTHbetween 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0mg/dL.

Exclusion Criteria:

• In the opinion of the Investigator, the subject currently has poorly controlleddiabetes 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 limitof 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. Ahistory of malignancy is not an exclusion.

• Current use of aluminum or magnesium based binders.