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

July 21, 2009 updated by: Ineos Healthcare Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Dose titration on active
Drug: Fermagate
Film coated tablet 500mg
Other Names:
  • Alpharen
ACTIVE_COMPARATOR: 2
Dose titration
Drug: Sevelamer HCl
tablet 800mg
Other Names:
  • RenaGel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of intolerance
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of QTc interval
Time Frame: 10 weeks
10 weeks
Change from baseline in serum electrolytes
Time Frame: 10 weeks
10 weeks
Change from baseline in parathyroid hormone (PTH)
Time Frame: 10 weeks
10 weeks
Reduction of serum magnesium removal during dialysis
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ineos Healthcare Limited

Investigators

  • Principal Investigator: Maarten Taal, MBChB MD FRCP, Derby City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

February 16, 2007

First Submitted That Met QC Criteria

February 16, 2007

First Posted (ESTIMATE)

February 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2009

Last Update Submitted That Met QC Criteria

July 21, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IH 003 (ACT3)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Failure

Clinical Trials on Fermagate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe