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| Sponsor: | Ineos Healthcare Limited |
|---|---|
| Information provided by: | Ineos Healthcare Limited |
| ClinicalTrials.gov Identifier: | NCT00436683 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Failure |
Drug: Fermagate Drug: Sevelamer HCl |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia. |
| Enrollment: | 64 |
| Study Start Date: | February 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Dose titration on active
|
Drug: Fermagate
Film coated tablet 500mg
Other Name: Alpharen
|
|
Active Comparator: 2
Dose titration
|
Drug: Sevelamer HCl
tablet 800mg
Other Name: RenaGel
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road | |
| Derby, Derbyshire, United Kingdom, DE22 3NE | |
| Queens Dialysis Unit, Rom Valley Way | |
| Romford, Essex, United Kingdom, RM7 0AG | |
| Renal Unit, Queen Elizabeth Hospital, Edgbaston | |
| Birmingham, United Kingdom, B15 2TH | |
| 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 | |
| Renal Dialysis Unit, Western Infirmary, Dumbarton Road | |
| Glasgow, United Kingdom, G11 6NT | |
| Renal Dialysis Unit, Gartnavel General Hospital | |
| Glasgow, United Kingdom, G12 0XP | |
| Renal Unit, St Bartholomew's Hospital, West Smithfield | |
| London, United Kingdom, EC1A 7BE | |
| Wanstead Renal Unit, 29 Cambridge Park, Wanstead | |
| London, United Kingdom, E11 2PU | |
| Renal Unit, The Royal London Hospital, Whitechapel | |
| London, United Kingdom, E1 1BB | |
| Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone | |
| London, United Kingdom, E11 1 NR | |
| Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd | |
| Manchester, United Kingdom, M23 9LT | |
| Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd | |
| Manchester, United Kingdom, M13 9WL | |
| Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd | |
| Reading, United Kingdom, RG1 5AN | |
| Renal Services, Hope Hospital | |
| Salford, United Kingdom, M6 8HD | |
| Principal Investigator: | Maarten Taal, MBChB MD FRCP | Derby City Hospital |
More Information
| Responsible Party: | Chief Medical Officer, INEOS Healthcare Limited |
| ClinicalTrials.gov Identifier: | NCT00436683 History of Changes |
| Other Study ID Numbers: | IH 003 (ACT3) |
| Study First Received: | February 16, 2007 |
| Last Updated: | July 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Hyperphosphataemia Phosphate binder |
|
Kidney Failure, Chronic Renal Insufficiency Hyperphosphatemia Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases |
Phosphorus Metabolism Disorders Metabolic Diseases Sevelamer Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |