Clinical trial NCT00436683: Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Official title: An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Failure
Keywords: Hyperphosphataemia
Phosphate binder
Lead sponsor: Ineos Healthcare Limited
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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 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

Primary outcomes:
measure: Assessment of intolerance
timeFrame: 10 weeks
Secondary outcomes:
measure: Assessment of QTc interval
timeFrame: 10 weeks
measure: Change from baseline in serum electrolytes
timeFrame: 10 weeks
measure: Change from baseline in parathyroid hormone (PTH)
timeFrame: 10 weeks
measure: Reduction of serum magnesium removal during dialysis
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road
state: Derbyshire
city: Romford
country: United Kingdom
facility: Queens Dialysis Unit, Rom Valley Way
state: Essex
city: Birmingham
country: United Kingdom
facility: Renal Unit, Queen Elizabeth Hospital, Edgbaston
city: Coventry
country: United Kingdom
facility: Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
city: Coventry
country: United Kingdom
facility: Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
city: Glasgow
country: United Kingdom
facility: Renal Dialysis Unit, Western Infirmary, Dumbarton Road
city: Glasgow
country: United Kingdom
facility: Renal Dialysis Unit, Gartnavel General Hospital
city: London
country: United Kingdom
facility: Renal Unit, The Royal London Hospital, Whitechapel
city: London
country: United Kingdom
facility: Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone
city: London
country: United Kingdom
facility: Wanstead Renal Unit, 29 Cambridge Park, Wanstead
city: London
country: United Kingdom
facility: Renal Unit, St Bartholomew's Hospital, West Smithfield
city: Manchester
country: United Kingdom
facility: Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd
city: Manchester
country: United Kingdom
facility: Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd
city: Reading
country: United Kingdom
facility: Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd
city: Salford
country: United Kingdom
facility: Renal Services, Hope Hospital
Study officials:
affiliation: Derby City Hospital
name: Maarten Taal, MBChB MD FRCP
role: PRINCIPAL_INVESTIGATOR
References: