Chronic Kidney FailurePhase 2ALCONNCT00358722
An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
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
Fermagate 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 the safety of fermagate over longer periods of time. 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?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jul 2006to Jun 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
- Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment
- Male or female subjects on active haemodialysis, aged 18 years or over
- 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;
- 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;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 with the exception of basal cell carcinoma;
- A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction;
Show all 14Show fewer
- A significant illness in the 4 weeks before screening;
- Taking medication for seizures;
- A history of haemochromatosis;
- A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation);
- A history of dysphagia or swallowing disorders;
- Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they abstain from sexual intercourse or 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, Little Horton Lane
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 Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Fermagate 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 the safety of fermagate over longer periods of time.
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).
This study is an open-label, multi-centre, single-group, 24-week study of fermagatebonate. Subjects participating in this study are those who took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.
- Conditions
- Chronic Kidney Failure
- Being tested
- Fermagate
- Medical subject headings
- Kidney Failure, Chronic
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
| Study group | Role | What they receive |
|---|---|---|
| Fermagate | Experimental | Not described Receives: Drug: Fermagate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of AEs and other safety parameters
Measured: 88 weeks
Secondary outcomes (1)
Assessment of serum phosphate concentrations
Measured: 88 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionMay 2008
- Study completionJun 2008
Why it stopped: Limited number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ineos Healthcare Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Simon Roe, MB ChB, Principal investigator, Nottingham City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358722
- Sponsor's protocol ID
- IH 002 (ALCON)
- Acronym
- ALCON
- Status last verified
- Jul 2009
- First submitted
- 31 Jul 2006
- Last updated
- 10 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
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 Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
- ClinicalTrials.gov ID
- NCT00358722
- Acronym / sponsor ID
- ALCON / IH 002 (ALCON)
- Conditions
- Chronic Kidney Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited number of subjects
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ineos Healthcare LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Aug 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.
Fermagate 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 the safety of fermagate over longer periods of time.
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).
This study is an open-label, multi-centre, single-group, 24-week study of fermagatebonate. Subjects participating in this study are those who took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fermagate | Experimental | Drug: Fermagate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment
- Male or female subjects on active haemodialysis, aged 18 years or over
- 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;
- Willing to maintain their usual type and dose of Vitamin D supplementation.
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 with the exception of basal cell carcinoma;
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 | Fermagate |
Primary outcome
Assessment of AEs and other safety parameters
Time frame: 88 weeks
1 secondary outcome
Assessment of serum phosphate concentrations
Time frame: 88 weeks
Results and safety
The study was stopped early (reason given: Limited number of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
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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 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 5 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: stopped early, 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. 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 was stopped early (reason given: Limited number of subjects). Results are not available in the source record.
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 AEs and other safety parameters (time frame: 88 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.