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Clinical Trial Details

Trial ID: L0951
Source ID: NCT00436683
Associated Drug: Fermagate
Title: Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Acronym: ACT3
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Failure
Interventions: DRUG: Fermagate|DRUG: Sevelamer HCl
Outcome Measures: Primary: Assessment of intolerance, 10 weeks | Secondary: 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
Sponsor/Collaborators: Sponsor: Ineos Healthcare Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-02
Completion Date: 2008-04
Results First Posted:
Last Update Posted: 2009-08-10
Locations: Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road, Derby, Derbyshire, DE22 3NE, United Kingdom|Queens Dialysis Unit, Rom Valley Way, Romford, Essex, RM7 0AG, United Kingdom|Renal Unit, Queen Elizabeth Hospital, Edgbaston, Birmingham, B15 2TH, United Kingdom|Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry, CV2 2DX, United Kingdom|Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry, CV2 2DX, United Kingdom|Renal Dialysis Unit, Western Infirmary, Dumbarton Road, Glasgow, G11 6NT, United Kingdom|Renal Dialysis Unit, Gartnavel General Hospital, Glasgow, G12 0XP, United Kingdom|Renal Unit, The Royal London Hospital, Whitechapel, London, E1 1BB, United Kingdom|Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone, London, E11 1 NR, United Kingdom|Wanstead Renal Unit, 29 Cambridge Park, Wanstead, London, E11 2PU, United Kingdom|Renal Unit, St Bartholomew's Hospital, West Smithfield, London, EC1A 7BE, United Kingdom|Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd, Manchester, M13 9WL, United Kingdom|Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd, Manchester, M23 9LT, United Kingdom|Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd, Reading, RG1 5AN, United Kingdom|Renal Services, Hope Hospital, Salford, M6 8HD, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00436683