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 determine how well a range of different doses of fermagate are tolerated by the subjects in the trial.
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. The purpose of this study is to determine the range of dosages which are tolerated by patients with hyperphosphatemia, undergoing haemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Film coated tablet 500mg
tablet 800mg
Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road
Derby, Derbyshire, United Kingdom
Assessment of intolerance
Time frame: 10 weeks
Assessment of QTc interval
Time frame: 10 weeks
Change from baseline in serum electrolytes
Time frame: 10 weeks
Change from baseline in parathyroid hormone (PTH)
Time frame: 10 weeks
Reduction of serum magnesium removal during dialysis
Time frame: 10 weeks
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