Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT00317694
Status:
COMPLETED
Last Update Posted:
2009-08-10
First Post:
2006-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
Sponsor:
Ineos Healthcare Limited
Organization:
Study Overview
Official Title:
A Multicentre Phase II Study With Magnesium Iron Hydroxycarbonate: an Open-label, Dose-ranging Phase Followed by a Placebo-controlled, Double-blind, Parallel-group Comparison 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:
None
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 it to look at how effective and safe Magnesium iron hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive hemodialysis.
The purpose of this study it to look at how effective and safe Magnesium iron hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive hemodialysis.
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 1.13 to 1.78 mmol/L in patients who receive hemodialysis.
This study is designed to investigate magnesium iron hydroxycarbonate's ability to lower and control patients' blood phosphate to the recommended levels and compare the average blood phosphate, calcium, calcium-phosphate product, PTH and magnesium concentrations and overall safety with placebo (or "dummy") tablets.
Current guidelines indicate that blood phosphorus levels should be maintained between 1.13 to 1.78 mmol/L in patients who receive hemodialysis.
This study is designed to investigate magnesium iron hydroxycarbonate's ability to lower and control patients' blood phosphate to the recommended levels and compare the average blood phosphate, calcium, calcium-phosphate product, PTH and magnesium concentrations and overall safety with placebo (or "dummy") tablets.
Study Oversight
Has Oversight DMC:
True
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?: