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ALCON: An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate

Sponsor
Ineos Healthcare Limited (Industry)
Overall Status
Terminated
CT.gov ID
NCT00358722
Collaborator
(none)
44
Enrollment
15
Locations
1
Arm
23
Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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).

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took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.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

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Study Start Date :
Jul 1, 2006
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fermagate

Drug: Fermagate
Film coated tablet 500mg
Other Names:
  • Alpharen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of AEs and other safety parameters [88 weeks]

    Secondary Outcome Measures

    1. Assessment of serum phosphate concentrations [88 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment

    2. Male or female subjects on active haemodialysis, aged 18 years or over

    3. Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium-, or iron-containing products and preparations, other than the study medication;

    4. Willing to avoid any intentional changes in diet such as fasting, dieting or overeating;

    5. Willing to maintain their usual type and dose of Vitamin D supplementation.

    Exclusion Criteria:

    1. Participation in any other clinical trial using an investigational product or device within the previous 4 months;

    2. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;

    3. 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;

    4. Clinically significant laboratory findings (for this subject population) in the opinion of the investigator.

    5. Any malignancy with the exception of basal cell carcinoma;

    6. A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction;

    7. A significant illness in the 4 weeks before screening;

    8. Taking medication for seizures;

    9. A history of haemochromatosis;

    10. A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation);

    11. A history of dysphagia or swallowing disorders;

    12. 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;

    13. Current haemoglobin concentration of < 10.00 g/dL;

    14. Allergy to the IMP or its constituents.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 1614 West 42nd Street Pine Bluff Arkansas United States 71603
    2 US Renal Care Stuttgart Arkansas United States 72160
    3 Davita Dialysis Center Charlotte North Carolina United States 28208
    4 Southeast Renal Associates Charlotte North Carolina United States 28208
    5 Renal Unit, Birmingham Heartlands Hospital Birmingham United Kingdom B9 5SS
    6 St Lukes Hospital, Little Horton Lane Bradford United Kingdom BD5 0NA
    7 Richard Bright Renal Unit, Southmead Hospital Bristol United Kingdom BS10 5NB
    8 Addenbrookes Dialysis Centre, Addenbrookes Hospital Cambridge United Kingdom CB2 2QQ
    9 Renal Unit, Leicester General Hospital Leicester United Kingdom LE5 4PW
    10 Dialysis Unit, Broad Green Hospital Liverpool United Kingdom L14 3LB
    11 Royal Liverpool University Hospital Liverpool United Kingdom L7 8XP
    12 General Medicine and Nephrology, Norfolk and Norwich University Hospital Norwich United Kingdom NR4 7RF
    13 Nottingham Renal and Transplant Unit, Nottingham City Hospital Nottingham United Kingdom NG5 1PB
    14 Sheffield Kidney Unit, Northern General Hospital Sheffield United Kingdom S5 7AU
    15 Dept. of Nephrology, Morriston Hospital Swansea United Kingdom SA6 6NL

    Sponsors and Collaborators

    • Ineos Healthcare Limited

    Investigators

    • Principal Investigator: Simon Roe, MB ChB, Nottingham City Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00358722
    Other Study ID Numbers:
    • IH 002 (ALCON)
    First Posted:
    Aug 1, 2006
    Last Update Posted:
    Aug 10, 2009
    Last Verified:
    Jul 1, 2009
    Additional relevant MeSH terms:
    Renal Insufficiency
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of Aug 10, 2009