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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
111
1614 West 42nd Street
Pine Bluff, Arkansas, United States
US Renal Care
Stuttgart, Arkansas, United States
Proportion of subjects who achieve controlled serum phosphate concentrations during the double-blind comparative phase
Time frame: Mean of last two serum phosphate values in the double blind phase
Change from baseline in mean serum phosphate concentration
Time frame: Mean of last two serum phosphate values
Change from baseline in serum calcium
Time frame: Specified visits throughout the study period
Change from baseline calcium-phosphate product
Time frame: Specified visits throughout the study period
Change from baseline PTH
Time frame: Specified visits throughout the study period
Change from baseline magnesium
Time frame: Specified visits throughout the study period
Assessment of adverse events
Time frame: Throughout the study period
Assessment of routine safety laboratory parameters
Time frame: Specified visits throughout the study period
Assessment of physical examination
Time frame: At screen and follow-up
Assessment of 12-lead electrocardiogram
Time frame: At screen and follow-up
Assessment of bowel habits
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...and 5 more locations
Time frame: Specified visits throughout the study period