Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324376
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2006-05-09
Brief Title:
Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Status:
COMPLETED
Status Verified Date:
2015-03
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:
A randomized cross-over open-label study will be conducted to evaluate the equivalency safety and tolerability of sevelamer once per day dosing given with the largest meal compared with standard three times per day dosing in hemodialysis patients previously using sevelamer Following a two week Run-In period a total of 24 patients will be randomized to one of the following treatment sequences
1 sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
2 sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening
1 sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
2 sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening
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