Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-29 @ 1:05 AM
Study NCT ID:
NCT00123461
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2005-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: