Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia (ACT3)

This study has been completed.
Sponsor:
Information provided by:
Ineos Healthcare Limited
ClinicalTrials.gov Identifier:
NCT00436683
First received: February 16, 2007
Last updated: July 21, 2009
Last verified: July 2009
  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 fermagate are tolerated by the subjects in the trial.


Condition Intervention Phase
Chronic Kidney Failure
Drug: Fermagate
Drug: Sevelamer HCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.

Resource links provided by NLM:


Further study details as provided by Ineos Healthcare Limited:

Primary Outcome Measures:
  • Assessment of intolerance [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of QTc interval [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum electrolytes [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in parathyroid hormone (PTH) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • Reduction of serum magnesium removal during dialysis [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose titration on active
Drug: Fermagate
Film coated tablet 500mg
Other Name: Alpharen
Active Comparator: 2
Dose titration
Drug: Sevelamer HCl
tablet 800mg
Other Name: RenaGel

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436683

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

No publications provided

Responsible Party: Chief Medical Officer, INEOS Healthcare Limited
ClinicalTrials.gov Identifier: NCT00436683     History of Changes
Other Study ID Numbers: IH 003 (ACT3)
Study First Received: February 16, 2007
Last Updated: July 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Ineos Healthcare Limited:
Hyperphosphataemia
Phosphate binder

Additional relevant MeSH terms:
Renal Insufficiency
Hyperphosphatemia
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 18, 2014