Chronic Kidney Failure Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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