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Sponsored by: |
Ineos Healthcare Limited |
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Information provided by: | Ineos Healthcare Limited |
ClinicalTrials.gov Identifier: | NCT00436683 |
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 magnesium iron hydroxycarbonate are tolerated by the subjects in the trial.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Failure |
Drug: Magnesium iron hydroxycarbonate Drug: Sevelamer |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia. |
Estimated Enrollment: | 60 |
Study Start Date: | February 2007 |
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 phosphorous 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Renal Unit, Queen Elizabeth Hospital, Edgbaston | |
Birmingham, United Kingdom, B15 2TH | |
Renal Dialysis Unit, Western Infirmary, Dumbarton Road | |
Glasgow, United Kingdom, G11 6NT | |
Renal Services, Hope Hospital | |
Salford, United Kingdom, M6 8HD | |
Wanstead Renal Unit, 29 Cambridge Park, Wanstead | |
London, United Kingdom, E11 2PU | |
Renal Unit, St Bartholomew's Hospital, West Smithfield | |
London, United Kingdom, EC1A 7BE | |
Renal Unit, The Royal London Hospital, Whitechapel | |
London, United Kingdom, E1 1BB | |
Renal Dialysis Unit, Gartnavel General Hospital | |
Glasgow, United Kingdom, G12 0XP | |
Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone | |
London, United Kingdom, E11 1 NR | |
Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road | |
Coventry, United Kingdom, CV2 2DX | |
Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road | |
Coventry, United Kingdom, CV2 2DX | |
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd | |
Manchester, United Kingdom, M13 9WL | |
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd | |
Manchester, United Kingdom, M23 9LT | |
Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd | |
Reading, United Kingdom, RG1 5AN | |
United Kingdom, Derbyshire | |
Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road | |
Derby, Derbyshire, United Kingdom, DE22 3NE | |
United Kingdom, Essex | |
Queens Dialysis Unit, Rom Valley Way | |
Romford, Essex, United Kingdom, RM7 0AG |
Study ID Numbers: | IH 003 (ACT 3) |
Study First Received: | February 16, 2007 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00436683 |
Health Authority: | United States: Food and Drug Administration |
Hyperphosphataemia Phosphate binder |
Sevelamer Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Hyperphosphatemia Kidney Diseases Metabolic disorder Iron Kidney Failure |
Phosphorus Metabolism Disorders |