Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418600
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2007-01-03
Brief Title:
A Phase 4 Conversion Study of Hectorol Injection to Hectorol Capsules in Stage 5 CKD Patients on Dialysis
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
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
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None