Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
NCT ID: NCT00436683
Last Updated: 2009-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2007-02-28
2008-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Dose titration on active
Fermagate
Film coated tablet 500mg
2
Dose titration
Sevelamer HCl
tablet 800mg
Interventions
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Fermagate
Film coated tablet 500mg
Sevelamer HCl
tablet 800mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ineos Healthcare Limited
INDUSTRY
Responsible Party
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INEOS Healthcare Limited
Principal Investigators
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Maarten Taal, MBChB MD FRCP
Role: PRINCIPAL_INVESTIGATOR
Derby City Hospital
Locations
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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
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
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
Renal Unit, St Bartholomew's Hospital, West Smithfield
London, , United Kingdom
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd
Manchester, , United Kingdom
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd
Manchester, , United Kingdom
Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd
Reading, , United Kingdom
Renal Services, Hope Hospital
Salford, , United Kingdom
Countries
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References
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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Other Identifiers
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IH 003 (ACT3)
Identifier Type: -
Identifier Source: org_study_id
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