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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Hectorol capsules at 1.0 times current injection dose
Hectorol capsules at 1.5 times current injection dose
Hectorol capsules at 2.0 times current injection dose
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Downey, California, United States
Unnamed facility
Tarzana, California, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Spokane, Washington, United States
Dose Conversion
Time frame: 5 weeks
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