Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-02 @ 5:06 AM
Study NCT ID:
NCT00268957
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2005-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
Sponsor:
Genzyme, a Sanofi Company
Organization:
Study Overview
Official Title:
A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis
Status:
COMPLETED
Status Verified Date:
2014-03
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:
Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.
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?: