Chronic Kidney FailurePhase 2ACT3NCT00436683
Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
A Phase 2 study testing Fermagate and Sevelamer HCl in people with Chronic Kidney Failure, run by Ineos Healthcare Limited at 15 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- Fermagate and Sevelamer HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- Feb 2007to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Renal Unit, Queen Elizabeth Hospital, Edgbaston
Birmingham, B15 2TH
Ash Haemodialysis Unit, Hospital of St Cross, University Hospital of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
Coventry, CV2 2DX
Haemodyialysis unit, Department of Nephrology, Walsgrave Hospital, University of Coventry & Warwickshire NHS Trust, Clifford Bridge Road
Coventry, CV2 2DX
Department of Renal Medicine, Derby City General Hospital, Uttoxeter Road
Derby, Derbyshire, DE22 3NE
Renal Dialysis Unit, Western Infirmary, Dumbarton Road
Glasgow, G11 6NT
Renal Dialysis Unit, Gartnavel General Hospital
Glasgow, G12 0XP
Renal Unit, The Royal London Hospital, Whitechapel
London, E1 1BB
Whipps Cross Renal Unit, Whipps Cross University Hospital, Whipps Cross Road, Leytonstone
London, E11 1 NR
Wanstead Renal Unit, 29 Cambridge Park, Wanstead
London, E11 2PU
Renal Unit, St Bartholomew's Hospital, West Smithfield
London, EC1A 7BE
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Manchester Royal Infirmary, Oxford Rd
Manchester, M13 9WL
Central Manchester & Manchester Childrens Hospital NHS Trust, Renal Dialysis Unit, Wythenshawe Hospital, Southmoor Rd
Manchester, M23 9LT
Haemodialysis Unit, Royal Berkshire Hospital, Royal Berkshire Hospital, Royal Berkshire NHS Foundation Trust, London Rd
Reading, RG1 5AN
Queens Dialysis Unit, Rom Valley Way
Romford, Essex, RM7 0AG
Renal Services, Hope Hospital
Salford, M6 8HD
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Failure
- Being tested
- Fermagate, Sevelamer HCl
- Keywords
- Hyperphosphataemia, Phosphate binder
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FermagateDrug
Also called Alpharen
Film coated tablet 500mg
Sevelamer HClDrug
Also called RenaGel
tablet 800mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose titration on active Receives: Drug: Fermagate |
| 2 | Active comparator | Dose titration Receives: Drug: Sevelamer HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of intolerance
Measured: 10 weeks
Secondary outcomes (4)
Assessment of QTc interval
Measured: 10 weeks
Change from baseline in serum electrolytes
Measured: 10 weeks
Change from baseline in parathyroid hormone (PTH)
Measured: 10 weeks
Reduction of serum magnesium removal during dialysis
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ineos Healthcare Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maarten Taal, MBChB MD FRCP, Principal investigator, Derby City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436683
- Sponsor's protocol ID
- IH 003 (ACT3)
- Acronym
- ACT3
- Status last verified
- Jul 2009
- First submitted
- 16 Feb 2007
- Last updated
- 10 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.
- ClinicalTrials.gov ID
- NCT00436683
- Acronym / sponsor ID
- ACT3 / IH 003 (ACT3)
- Conditions
- Chronic Kidney Failure
- Keywords
- Hyperphosphataemia, Phosphate binder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ineos Healthcare LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FermagateDose titration on active |
| 2 | Active comparator | Drug: Sevelamer HClDose titration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FermagateAlso: AlpharenFilm coated tablet 500mg | Drug | 1 |
| Sevelamer HClAlso: RenaGeltablet 800mg | Drug | 2 |
Primary outcome
Assessment of intolerance
Time frame: 10 weeks
4 secondary outcomes
Assessment of QTc interval
Time frame: 10 weeks
Change from baseline in serum electrolytes
Time frame: 10 weeks
Change from baseline in parathyroid hormone (PTH)
Time frame: 10 weeks
Reduction of serum magnesium removal during dialysis
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
- Derived from this study: PubMed 40576086Natale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Taal, MBChB MD FRCP principal investigator
Derby City Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fermagate and Sevelamer HCl in people with Chronic Kidney Failure, run by Ineos Healthcare Limited at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of intolerance (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00436683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2009.