ACT3: Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Dose titration on active |
Drug: Fermagate
Film coated tablet 500mg
Other Names:
|
| Active Comparator: 2 Dose titration |
Drug: Sevelamer HCl
tablet 800mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Assessment of intolerance [10 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road | Derby | Derbyshire | United Kingdom | DE22 3NE |
| 2 | Queens Dialysis Unit, Rom Valley Way | Romford | Essex | United Kingdom | RM7 0AG |
| 3 | Renal Unit, Queen Elizabeth Hospital, Edgbaston | Birmingham | United Kingdom | B15 2TH | |
| 4 | Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road | Coventry | United Kingdom | CV2 2DX | |
| 5 | Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road | Coventry | United Kingdom | CV2 2DX | |
| 6 | Renal Dialysis Unit, Western Infirmary, Dumbarton Road | Glasgow | United Kingdom | G11 6NT | |
| 7 | Renal Dialysis Unit, Gartnavel General Hospital | Glasgow | United Kingdom | G12 0XP | |
| 8 | Renal Unit, The Royal London Hospital, Whitechapel | London | United Kingdom | E1 1BB | |
| 9 | Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone | London | United Kingdom | E11 1 NR | |
| 10 | Wanstead Renal Unit, 29 Cambridge Park, Wanstead | London | United Kingdom | E11 2PU | |
| 11 | Renal Unit, St Bartholomew's Hospital, West Smithfield | London | United Kingdom | EC1A 7BE | |
| 12 | Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd | Manchester | United Kingdom | M13 9WL | |
| 13 | Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd | Manchester | United Kingdom | M23 9LT | |
| 14 | Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd | Reading | United Kingdom | RG1 5AN | |
| 15 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IH 003 (ACT3)