Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
Completed
Genzyme, a Sanofi Company
Phase 4
2005-07-01
The purpose of this study is to demonstrate the safety and effectiveness of Hectorol®
(doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney
disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal
range. Previous studies with doxercalciferol were conducted in patients who had low levels of
vitamin D.
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
Completed
Abbott
Phase 4
2006-06-01
The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol®
Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on
hemodialysis.
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Completed
Genzyme, a Sanofi Company
Phase 4
2006-11-01
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.
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