Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
ACT3
An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.
1 other identifier
interventional
64
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2007
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedAugust 10, 2009
July 1, 2009
11 months
February 16, 2007
July 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of intolerance
10 weeks
Secondary Outcomes (4)
Assessment of QTc interval
10 weeks
Change from baseline in serum electrolytes
10 weeks
Change from baseline in parathyroid hormone (PTH)
10 weeks
Reduction of serum magnesium removal during dialysis
10 weeks
Study Arms (2)
1
EXPERIMENTALDose titration on active
2
ACTIVE COMPARATORDose titration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road
Derby, Derbyshire, DE22 3NE, United Kingdom
Queens Dialysis Unit, Rom Valley Way
Romford, Essex, RM7 0AG, United Kingdom
Renal Unit, Queen Elizabeth Hospital, Edgbaston
Birmingham, B15 2TH, United Kingdom
Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
Coventry, CV2 2DX, United Kingdom
Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
Coventry, CV2 2DX, United Kingdom
Renal Dialysis Unit, Western Infirmary, Dumbarton Road
Glasgow, G11 6NT, United Kingdom
Renal Dialysis Unit, Gartnavel General Hospital
Glasgow, G12 0XP, United Kingdom
Renal Unit, The Royal London Hospital, Whitechapel
London, E1 1BB, United Kingdom
Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone
London, E11 1 NR, United Kingdom
Wanstead Renal Unit, 29 Cambridge Park, Wanstead
London, E11 2PU, United Kingdom
Renal Unit, St Bartholomew's Hospital, West Smithfield
London, EC1A 7BE, United Kingdom
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd
Manchester, M13 9WL, United Kingdom
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd
Manchester, M23 9LT, United Kingdom
Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd
Reading, RG1 5AN, United Kingdom
Renal Services, Hope Hospital
Salford, M6 8HD, United Kingdom
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten Taal, MBChB MD FRCP
Derby City Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
February 1, 2007
Primary Completion
January 1, 2008
Study Completion
April 1, 2008
Last Updated
August 10, 2009
Record last verified: 2009-07