Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123461
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2005-07-21
Brief Title:
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease Stage 3 or 4 and Secondary Hyperparathyroidism
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 4 Multi-center Randomized Double-blind Placebo-controlled Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease CKD Stages 3 or 4 With Secondary Hyperparathyroidism SHPT
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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