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

Chronic Kidney Failure Clinical Trial

— ACT3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436683
• Other study ID #: IH 003 (ACT3)
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2007
• Last updated: July 21, 2009
• Start date: February 2007
• Est. completion date: April 2008

Study information

• Verified date: July 2009
• Source: Ineos Healthcare Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Hyperphosphatemia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Fermagate
Film coated tablet 500mg
• Sevelamer HCl
tablet 800mg

Locations

Country	Name	City	State
United Kingdom	Renal Unit, Queen Elizabeth Hospital, Edgbaston	Birmingham
United Kingdom	Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road	Coventry
United Kingdom	Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road	Coventry
United Kingdom	Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road	Derby	Derbyshire
United Kingdom	Renal Dialysis Unit, Gartnavel General Hospital	Glasgow
United Kingdom	Renal Dialysis Unit, Western Infirmary, Dumbarton Road	Glasgow
United Kingdom	Renal Unit, St Bartholomew's Hospital, West Smithfield	London
United Kingdom	Renal Unit, The Royal London Hospital, Whitechapel	London
United Kingdom	Wanstead Renal Unit, 29 Cambridge Park, Wanstead	London
United Kingdom	Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone	London
United Kingdom	Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd	Manchester
United Kingdom	Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd	Manchester
United Kingdom	Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd	Reading
United Kingdom	Queens Dialysis Unit, Rom Valley Way	Romford	Essex
United Kingdom	Renal Services, Hope Hospital	Salford

Sponsors (1)

Lead Sponsor	Collaborator
Ineos Healthcare Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of intolerance		10 weeks	Yes
Secondary	Assessment of QTc interval		10 weeks	Yes
Secondary	Change from baseline in serum electrolytes		10 weeks	Yes
Secondary	Change from baseline in parathyroid hormone (PTH)		10 weeks	Yes
Secondary	Reduction of serum magnesium removal during dialysis		10 weeks	Yes