Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride
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.
|Chronic Kidney Failure||Drug: Fermagate Drug: Sevelamer hydrochloride||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Control or not the level of serum phosphate [ Time Frame: Within the treatment period ]
- Change from baseline in mean serum phosphate [ Time Frame: End of 3 months treatment in maintenance period ]
- Change from baseline in calcium, calcium phosphate product and PTH level [ Time Frame: End of 3 months treatment in maintenance period ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Film coated tablet 500mg
Other Name: Alpharen
|Active Comparator: 2||
Drug: Sevelamer hydrochloride
Other Name: Renagel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844662
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|Study Chair:||Chief Medical Officer (Information at Ineos Healthcare Limited), Dr.||Ineos Healthcare Limited|