Chronic Kidney Failure Clinical Trial
Official title:
A Multicentre Phase II Study With Magnesium Iron Hydroxycarbonate: an Open-label, Dose-ranging Phase Followed by a Placebo-controlled, Double-blind, Parallel-group Comparison in Haemodialysis Subjects 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 it to look at how effective and safe Magnesium iron
hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive
hemodialysis.
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).
Current guidelines indicate that blood phosphorus levels should be maintained between 1.13
to 1.78 mmol/L in patients who receive hemodialysis.
This study is designed to investigate magnesium iron hydroxycarbonate's ability to lower and
control patients' blood phosphate to the recommended levels and compare the average blood
phosphate, calcium, calcium-phosphate product, PTH and magnesium concentrations and overall
safety with placebo (or "dummy") tablets.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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