A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
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.