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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.

Conditions
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Chronic Kidney Failure

Intervention / Treatment
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* Drug: Fermagate
* Drug: Sevelamer HCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose titration on active | Drug: Fermagate<br>* Film coated tablet 500mg<br>* Other names: Alpharen;|
| Active Comparator: 2<br>Dose titration | Drug: Sevelamer HCl<br>* tablet 800mg<br>* Other names: RenaGel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of intolerance |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperphosphataemia, Phosphate binder