Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358722
Status:
TERMINATED
Last Update Posted:
2009-08-10
First Post:
2006-07-31
Brief Title:
An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
Sponsor:
Ineos Healthcare Limited
Organization:
Ineos Healthcare Limited
Study Overview
Official Title:
A Long-term Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Limited number of subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALCON
Brief Summary:
Fermagate is a phosphate binder that absorbs phosphate from food reducing the amount that the body can absorb
The purpose of this study it to look at the safety of fermagate over longer periods of time
The purpose of this study it to look at the safety of fermagate over longer periods of time
Detailed Description:
High levels of phosphate in the blood are linked with serious effects due to calcium imbalances high levels of parathyroid hormone PTH bone disease formation of calcium deposits in the body and blood-vessel disease
This study is an open-label multi-centre single-group 24-week study of fermagatebonate Subjects participating in this study are those who took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event AE considered related to study treatment
This study is an open-label multi-centre single-group 24-week study of fermagatebonate Subjects participating in this study are those who took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event AE considered related to study treatment
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