Status:
COMPLETED
Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Lead Sponsor:
Ineos Healthcare Limited
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 dif...
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...
Eligibility Criteria
Inclusion
- 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
- 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00436683
Start Date
February 1 2007
End Date
April 1 2008
Last Update
August 10 2009
Active Locations (15)
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1
Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road
Derby, Derbyshire, United Kingdom, DE22 3NE
2
Queens Dialysis Unit, Rom Valley Way
Romford, Essex, United Kingdom, RM7 0AG
3
Renal Unit, Queen Elizabeth Hospital, Edgbaston
Birmingham, United Kingdom, B15 2TH
4
Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
Coventry, United Kingdom, CV2 2DX