Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Dose Ranging Study of Magnesium Iron Hydroxycarbonate 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 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.
Inclusion Criteria:

 -  Male or female subjects on active haemodialysis, aged 18 years or over who are able to
 comply with study procedures

 -  Written informed consent given

 -  On a stable haemodialysis regimen (three times per week) for at least 3 months and be
 unlikely to change their dialysis prescription during the study period

 -  On a stable dose of phosphate binder for at least 1 month prior to screening

 -  Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium- or
 iron-containing products and preparations, other than the study medication

 -  Willing to avoid any intentional changes in diet such as fasting, dieting or
 overeating

 -  On a dialysate magnesium ion concentration of ≤1.0 mmol/L for at least 1 month prior
 to screening

 Exclusion Criteria:

 -  Received a cardiac transplant

 -  Heart failure according to New York Heart Association (NYHA) Functional IV
 Classification

 -  Participation in any other clinical trial using an investigational product or device
 within the previous 4 weeks

 -  A significant history of alcohol, drug or solvent abuse in the opinion of the
 investigator

 -  Any disease or condition, physical or psychological, which in the opinion of the
 investigator would compromise the safety of the subject or increase the likelihood of
 the subject being withdrawn

 -  Clinically significant laboratory findings (at screening for this subject population)
 in the opinion of the investigator

 -  Any history of recent clinically significant malignancy

 -  A significant illness (excluding renal disease) in the 4 weeks before screening

 -  A history of poorly controlled epilepsy

 -  Female subjects who are lactating or pregnant. Women of childbearing potential
 (pre-menopausal and not surgically sterilised) unless they are using a reliable
 contraceptive method, that is, barrier methods, hormones or intrauterine device

 -  Allergy to magnesium iron hydroxycarbonate or sevelamer or any component of the
 formulations

 -  Any condition that affects the reliability of measuring QT interval, for example, an
 irregular heart rhythm such as atrial fibrillation or frequent ectopic activity