Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436683
Status:
COMPLETED
Last Update Posted:
2009-08-10
First Post:
2007-02-16
Brief Title:
Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Sponsor:
Ineos Healthcare Limited
Organization:
Ineos Healthcare Limited
Study Overview
Official Title:
An Open Label Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Status:
COMPLETED
Status Verified Date:
2009-07
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:
ACT3
Brief Summary:
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food reducing the amount that the body can absorb
The purpose of this study is to determine how well a range of different doses of fermagate are tolerated by the subjects in the trial
The purpose of this study is to determine how well a range of different doses of fermagate are tolerated by the subjects in the trial
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
Current guidelines indicate that blood phosphorus levels should be maintained between 113 to 178 mmolL in patients who receive hemodialysis
The purpose of this study is to determine the range of dosages which are tolerated by patients with hyperphosphatemia undergoing haemodialysis
Current guidelines indicate that blood phosphorus levels should be maintained between 113 to 178 mmolL in patients who receive hemodialysis
The purpose of this study is to determine the range of dosages which are tolerated by patients with hyperphosphatemia undergoing haemodialysis
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