NCT00844662

Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride

An Open, Randomised, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride in Haemodialysis Patients With Hyperphosphataemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• 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 is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride.

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 deposites in the body and blood-vessel disease. Current guidelines indicate that blood phosphorous levels should be maintained between 1.13 to 1.78mmol/L in patients who receive haemodialysis. The purpose of this study is to establish the non-inferiority of magnesium iron hydroxycarbonate to sevelamer hydrochloride in lowering serum phosphate in haemodialysis patients treated for 3 months. Additional objectives: (1) to determine the safety of magnesium iron hydroxycarbonate after short term (3 months) and long term (6 and 12 months) treatment, (2)to determine the efficacy of magnesium iron hydroxycarbonate after long term treatment (6 and 12 months) and (3) To compare the effects of magnesium iron hydroxycarbonate and sevelamer hydrochloride on measures of mineral metabolism, albumin, pre-albumin and iron status after short term (3 months) and long term (6 and 12 months) treatment.

Conditions

• Chronic Kidney Failure

Interventions

Type	Name	Description
DRUG	Fermagate	Film coated tablet 500mg
DRUG	Sevelamer hydrochloride	Tablet 800mg

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2009-02-16
• Last updated: 2010-10-19

Locations

109 sites across 15 countries: United States, Belgium, Brazil, Bulgaria, Czechia, Estonia, Hungary, Israel, Italy, Lithuania, Mexico, Serbia, Slovakia, South Africa, United Kingdom