Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia

Condition(s) targeted: Chronic Kidney Failure

Intervention: Magnesium iron hydroxycarbonate (Drug); Sevelamer (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Ineos Healthcare Limited

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.

Official title: An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Assessment of intolerance

Secondary outcome:

Assessment of QTc interval

Change from baseline in serum electrolytes

Change from baseline in parathyroid hormone (PTH)

Reduction of serum magnesium removal during dialysis

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Renal Unit, Queen Elizabeth Hospital, Edgbaston, Birmingham B15 2TH, United Kingdom

Renal Dialysis Unit, Western Infirmary, Dumbarton Road, Glasgow G11 6NT, United Kingdom

Renal Services, Hope Hospital, Salford M6 8HD, United Kingdom

Renal Dialysis Unit, Gartnavel General Hospital, Glasgow G12 0XP, United Kingdom

Renal Unit, St Bartholomew's Hospital, West Smithfield, London EC1A 7BE, United Kingdom

Renal Unit, The Royal London Hospital, Whitechapel, London E1 1BB, United Kingdom

Wanstead Renal Unit, 29 Cambridge Park, Wanstead, London E11 2PU, United Kingdom

Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone, London E11 1 NR, United Kingdom

Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry CV2 2DX, United Kingdom

Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry CV2 2DX, 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

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

Starting date: February 2007
Last updated: January 28, 2008