Chronic Kidney FailurePhase 2NCT00317694
Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
A Phase 2 study testing Fermagate in people with Chronic Kidney Failure, run by Ineos Healthcare Limited at 15 sites in 2 countries.
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 it to look at how effective and safe Magnesium iron hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive hemodialysis. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Mar 2006to Jun 2007
- 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.
- 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 a phosphate binder for at least 1 month prior to screening.
- Willing to abstain from taking any phosphate binder or oral magnesium, aluminum 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.
- Willing to maintain their usual type and dose of Vitamin D supplementation.
Who cannot join
- Participation in any other clinical trial using an investigational product or device within the previous 4 months.
- 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn.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 (for this subject population) in the opinion of the investigator.
- Any malignancy requiring treatment within 5 years of screening with the exception of basal cell carcinoma and Bowen's disease.
- A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction.
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- A significant illness in the 4 weeks before screening.
- Taking medication prescribed for seizures.
- A history of haemochromatosis.
- A history of high serum ferritin concentration of ≥ 1000ng/ml (excluding transient, treatment-induced ferritin elevation).
- A history of dysphagia or swallowing disorders that might limit the subject's ability to swallow study medication in the opinion of the investigator.
- Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilized) unless they are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device.
- Current haemoglobin concentration of < 10.00 g/dL.
- Allergy to the IMP or its constituents.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United Kingdom11 sites
Renal Unit, Birmingham Heartlands Hospital
Birmingham, B9 5SS
St Lukes Hospital
Bradford, BD5 0NA
Richard Bright Renal Unit, Southmead Hospital
Bristol, BS10 5NB
Addenbrookes Dialysis Centre, Addenbrookes Hospital
Cambridge, CB2 2QQ
Renal Unit, Leicester General Hospital
Leicester, LE5 4PW
Dialysis Unit, Broad Green Hospital
Liverpool, L14 3LB
Royal Liverpool University Hospital
Liverpool, L7 8XP
General Medicine and Nephrology, Norfolk and Norwich University Hospital
Norwich, NR4 7RF
Nottingham Renal and Transplant Unit, Nottingham City Hospital
Nottingham, NG5 1PB
Sheffield Kidney Unit, Northern General Hospital
Sheffield, S5 7AU
Dept. of Nephrology, Morriston Hospital
Swansea, SA6 6NL
United States4 sites
Davita Dialysis Center
Charlotte, North Carolina, 28208
Southeast Renal Associates
Charlotte, North Carolina, 28208
1614 West 42nd Street
Pine Bluff, Arkansas, 71603
US Renal Care
Stuttgart, Arkansas, 72160
About this study
Official title: A Multicentre Phase II Study With Magnesium Iron Hydroxycarbonate: an Open-label, Dose-ranging Phase Followed by a Placebo-controlled, Double-blind, Parallel-group Comparison 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 it to look at how effective and safe Magnesium iron hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive hemodialysis.
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.
This study is designed to investigate magnesium iron hydroxycarbonate's ability to lower and control patients' blood phosphate to the recommended levels and compare the average blood phosphate, calcium, calcium-phosphate product, PTH and magnesium concentrations and overall safety with placebo (or "dummy") tablets.
- Conditions
- Chronic Kidney Failure
- Being tested
- Fermagate, Placebo
- Keywords
- Hyperphosphatemia, 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 Magnesium iron hydroxycarbonate
Film coated tablet 500mg
PlaceboDrug
Oral administration, film coated tablet, 0mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fermagate |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve controlled serum phosphate concentrations during the double-blind comparative phase
Measured: Mean of last two serum phosphate values in the double blind phase
Secondary outcomes (10)
Change from baseline in mean serum phosphate concentration
Measured: Mean of last two serum phosphate values
Change from baseline in serum calcium
Measured: Specified visits throughout the study period
Change from baseline calcium-phosphate product
Measured: Specified visits throughout the study period
Change from baseline PTH
Measured: Specified visits throughout the study period
Change from baseline magnesium
Measured: Specified visits throughout the study period
Assessment of adverse events
Measured: Throughout the study period
Assessment of routine safety laboratory parameters
Measured: Specified visits throughout the study period
Assessment of physical examination
Measured: At screen and follow-up
Assessment of 12-lead electrocardiogram
Measured: At screen and follow-up
Assessment of bowel habits
Measured: Specified visits throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ineos Healthcare Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Simon Roe, MB ChB, Principal investigator, Nottingham Renal and Transplant Unit, Nottingham City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317694
- Sponsor's protocol ID
- IH 001 (ACT 2)
- Status last verified
- Jul 2009
- First submitted
- 21 Apr 2006
- 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
- A Multicentre Phase II Study With Magnesium Iron Hydroxycarbonate: an Open-label, Dose-ranging Phase Followed by a Placebo-controlled, Double-blind, Parallel-group Comparison in Haemodialysis Subjects With Hyperphosphataemia
- ClinicalTrials.gov ID
- NCT00317694
- Acronym / sponsor ID
- IH 001 (ACT 2)
- Conditions
- Chronic Kidney Failure
- Keywords
- Hyperphosphatemia, Phosphate binder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Ineos Healthcare LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 25 Apr 2006 (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 it to look at how effective and safe Magnesium iron hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive hemodialysis.
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.
This study is designed to investigate magnesium iron hydroxycarbonate's ability to lower and control patients' blood phosphate to the recommended levels and compare the average blood phosphate, calcium, calcium-phosphate product, PTH and magnesium concentrations and overall safety with placebo (or "dummy") tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fermagate |
| 2 | Placebo comparator | Drug: Placebo |
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.
- 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 a phosphate binder for at least 1 month prior to screening.
- Willing to abstain from taking any phosphate binder or oral magnesium, aluminum or iron-containing products and preparations, other than the study medication.
Key exclusion criteria (14 listed)
- Participation in any other clinical trial using an investigational product or device within the previous 4 months.
- 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 (for this subject population) in the opinion of the investigator.
- Any malignancy requiring treatment within 5 years of screening with the exception of basal cell carcinoma and Bowen's disease.
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: Magnesium iron hydroxycarbonateFilm coated tablet 500mg | Drug | 1 |
| PlaceboOral administration, film coated tablet, 0mg | Drug | 2 |
Primary outcome
Proportion of subjects who achieve controlled serum phosphate concentrations during the double-blind comparative phase
Time frame: Mean of last two serum phosphate values in the double blind phase
10 secondary outcomes
Change from baseline in mean serum phosphate concentration
Time frame: Mean of last two serum phosphate values
Change from baseline in serum calcium
Time frame: Specified visits throughout the study period
Change from baseline calcium-phosphate product
Time frame: Specified visits throughout the study period
Change from baseline PTH
Time frame: Specified visits throughout the study period
Change from baseline magnesium
Time frame: Specified visits throughout the study period
Assessment of adverse events
Time frame: Throughout the study period
Assessment of routine safety laboratory parameters
Time frame: Specified visits throughout the study period
Assessment of physical examination
Time frame: At screen and follow-up
Assessment of 12-lead electrocardiogram
Time frame: At screen and follow-up
Assessment of bowel habits
Time frame: Specified visits throughout the study period
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.
Simon Roe, MB ChB principal investigator
Nottingham Renal and Transplant Unit, Nottingham City Hospital
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fermagate in people with Chronic Kidney Failure, run by Ineos Healthcare Limited at 15 sites in 2 countries.
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 14 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, United States. 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. Some participants in this study may receive a placebo. 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?
Proportion of subjects who achieve controlled serum phosphate concentrations during the double-blind comparative phase (time frame: Mean of last two serum phosphate values in the double blind phase). 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 NCT00317694, 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.