Trials / Completed
CompletedNCT00418600
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
A Phase 4, Multi-Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® Capsules When Converting From Hectorol® Injection for the Treatment of SHPT in Stage 5 CKD Subjects on Hemodialysis
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hectorol® (doxercalciferol capsules) | Hectorol capsules at 1.0 times current injection dose |
| DRUG | doxercalciferol capsules, Hectorol® | Hectorol capsules at 1.5 times current injection dose |
| DRUG | doxercalciferol capsules, Hectorol® capsules | Hectorol capsules at 2.0 times current injection dose |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2007-06-01
- Completion
- 2007-08-01
- First posted
- 2007-01-05
- Last updated
- 2015-03-19
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00418600. Inclusion in this directory is not an endorsement.