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Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia (ACT 3)
This study is ongoing, but not recruiting participants.
Sponsored by: 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 magnesium iron hydroxycarbonate are tolerated by the subjects in the trial.


Condition Intervention Phase
Chronic Kidney Failure
Drug: Magnesium iron hydroxycarbonate
Drug: Sevelamer
Phase II

MedlinePlus related topics: Dialysis Kidney Failure
Drug Information available for: Magnesium Sevelamer Sevelamer carbonate Sevelamer hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.

Further study details as provided by Ineos Healthcare Limited:

Primary Outcome Measures:
  • Assessment of intolerance

Secondary Outcome Measures:
  • Assessment of QTc interval
  • Change from baseline in serum electrolytes
  • Change from baseline in parathyroid hormone (PTH)
  • Reduction of serum magnesium removal during dialysis

Estimated Enrollment: 60
Study Start Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436683

Locations
United Kingdom
Renal Unit, Queen Elizabeth Hospital, Edgbaston
Birmingham, United Kingdom, B15 2TH
Renal Dialysis Unit, Western Infirmary, Dumbarton Road
Glasgow, United Kingdom, G11 6NT
Renal Services, Hope Hospital
Salford, United Kingdom, M6 8HD
Wanstead Renal Unit, 29 Cambridge Park, Wanstead
London, United Kingdom, E11 2PU
Renal Unit, St Bartholomew's Hospital, West Smithfield
London, United Kingdom, EC1A 7BE
Renal Unit, The Royal London Hospital, Whitechapel
London, United Kingdom, E1 1BB
Renal Dialysis Unit, Gartnavel General Hospital
Glasgow, United Kingdom, G12 0XP
Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone
London, United Kingdom, E11 1 NR
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
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd
Manchester, United Kingdom, M13 9WL
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd
Manchester, United Kingdom, M23 9LT
Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd
Reading, United Kingdom, RG1 5AN
United Kingdom, Derbyshire
Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road
Derby, Derbyshire, United Kingdom, DE22 3NE
United Kingdom, Essex
Queens Dialysis Unit, Rom Valley Way
Romford, Essex, United Kingdom, RM7 0AG
Sponsors and Collaborators
Ineos Healthcare Limited
  More Information

Study ID Numbers: IH 003 (ACT 3)
Study First Received: February 16, 2007
Last Updated: January 28, 2008
ClinicalTrials.gov Identifier: NCT00436683  
Health Authority: United States: Food and Drug Administration

Keywords provided by Ineos Healthcare Limited:
Hyperphosphataemia
Phosphate binder

Study placed in the following topic categories:
Sevelamer
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperphosphatemia
Kidney Diseases
Metabolic disorder
Iron
Kidney Failure

Additional relevant MeSH terms:
Phosphorus Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009