Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn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

Arm && Interventions

Group	Intervention	Description
1	Fermagate	Dose titration on active
2	Sevelamer HCl	Dose titration

Primary Outcome Measures

Name	Time	Method
Assessment of intolerance	10 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of QTc interval	10 weeks
Change from baseline in serum electrolytes	10 weeks
Change from baseline in parathyroid hormone (PTH)	10 weeks
Reduction of serum magnesium removal during dialysis	10 weeks

Locations (15): Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road
🇬🇧
Derby, Derbyshire, United Kingdom
Queens Dialysis Unit, Rom Valley Way
🇬🇧
Romford, Essex, United Kingdom
Renal Unit, Queen Elizabeth Hospital, Edgbaston
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Birmingham, United Kingdom
Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
🇬🇧
Coventry, United Kingdom
Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
🇬🇧
Coventry, United Kingdom
Renal Dialysis Unit, Western Infirmary, Dumbarton Road
🇬🇧
Glasgow, United Kingdom
Renal Dialysis Unit, Gartnavel General Hospital
🇬🇧
Glasgow, United Kingdom
Renal Unit, The Royal London Hospital, Whitechapel
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London, United Kingdom
Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone
🇬🇧
London, United Kingdom
Wanstead Renal Unit, 29 Cambridge Park, Wanstead
🇬🇧
London, United Kingdom
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Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road
🇬🇧Derby, Derbyshire, United Kingdom