NCT00317694

Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Ineos Healthcare Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Kidney Failure

Interventions

Type	Name	Description
DRUG	Fermagate	Film coated tablet 500mg
DRUG	Placebo	Oral administration, film coated tablet, 0mg

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-04-25
• Last updated: 2009-08-10

Locations

15 sites across 2 countries: United States, United Kingdom