NCT00841126

Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate

An Open, Randomized, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate Together With a Randomized Placebo Controlled Double Blind Fermagate Comparison in Hemodialysis Patients With Hyperphosphatemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 657 (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 hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.

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 1.78 mmol/L in patients who receive hemodialysis. This is a 2-stage re-randomization design where Stage 1 is a randomized, open label comparison between fermagate and lanthanum carbonate (in a non-inferiority design) and Stage 2 is a randomized double blind comparison between fermagate and placebo (in a superiority design). Objectives at Stage 1: Primary Objective: The primary objective is to establish the efficacy of fermagate by demonstrating the noninferiority (with possible assessment of superiority) of fermagate to lanthanum carbonate in lowering serum phosphate in hemodialysis patients. Secondary objectives: The secondary objectives are to: 1. Determine the safety of fermagate in hemodialysis patients. 2. Compare the effects of fermagate and lanthanum carbonate on measures of mineral metabolism, albumin, pre-albumin and iron status. Objectives at Stage 2: Stage 2 will use patients who complete the 3-month maintenance period of Stage 1 and who were originally randomized to fermagate. Primary Objective: The primary objective is to establish efficacy of fermagate by demonstrating the superiority of fermagate over placebo in lowering serum phosphate in hemodialysis patients. Secondary objectives: The secondary objectives are to: 1. Determine the safety of fermagate in hemodialysis patients. 2. Compare the effects of fermagate and placebo on measures of mineral metabolism, albumin, pre-albumin and iron status.

Conditions

• Chronic Kidney Failure

Interventions

Type	Name	Description
DRUG	Magnesium iron hydroxycarbonate	500 mg tablets, administered orally: initial dosage 500 or 1000 mg (total daily dose 1500 or 3000 mg) depending on serum phosphate concentration, titrated to a maximum DAILY dose of 9000 mg). The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 3000 mg.
DRUG	Lanthanum carbonate	750 mg chewable tablets, administered orally: initial dosage 750 mg up to 3-times daily (total daily dose 2250 mg), titrated to a maximum SINGLE dose of 1500 mg (DAILY dose 3750 mg). The total daily dose should be divided and taken with meals.
DRUG	Placebo	0 mg (500 mg-size) tablets, administered orally: The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 6 tablets.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-02-11
• Last updated: 2010-10-19

Locations

112 sites across 11 countries: United States, Australia, Brazil, Canada, France, Germany, Malta, New Zealand, Poland, South Africa, Spain