NCT00358722

An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate

A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Ineos Healthcare Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.

Conditions

• Chronic Kidney Failure

Interventions

Type	Name	Description
DRUG	Fermagate	Film coated tablet 500mg

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-05-01
• Completion: 2008-06-01
• First posted: 2006-08-01
• Last updated: 2009-08-10

Locations

15 sites across 2 countries: United States, United Kingdom