An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
NCT ID: NCT00358722
Last Updated: 2009-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
44 participants
INTERVENTIONAL
2006-07-31
2008-06-30
Brief Summary
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The purpose of this study it to look at the safety of fermagate over longer periods of time.
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Detailed Description
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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took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fermagate
Fermagate
Film coated tablet 500mg
Interventions
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Fermagate
Film coated tablet 500mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;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.
18 Years
ALL
No
Sponsors
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Ineos Healthcare Limited
INDUSTRY
Responsible Party
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Ineos Healthcare Limited
Principal Investigators
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Simon Roe, MB ChB
Role: PRINCIPAL_INVESTIGATOR
Nottingham City Hospital
Locations
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1614 West 42nd Street
Pine Bluff, Arkansas, United States
US Renal Care
Stuttgart, Arkansas, United States
Davita Dialysis Center
Charlotte, North Carolina, United States
Southeast Renal Associates
Charlotte, North Carolina, United States
Renal Unit, Birmingham Heartlands Hospital
Birmingham, , United Kingdom
St Lukes Hospital, Little Horton Lane
Bradford, , United Kingdom
Richard Bright Renal Unit, Southmead Hospital
Bristol, , United Kingdom
Addenbrookes Dialysis Centre, Addenbrookes Hospital
Cambridge, , United Kingdom
Renal Unit, Leicester General Hospital
Leicester, , United Kingdom
Dialysis Unit, Broad Green Hospital
Liverpool, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
General Medicine and Nephrology, Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Nottingham Renal and Transplant Unit, Nottingham City Hospital
Nottingham, , United Kingdom
Sheffield Kidney Unit, Northern General Hospital
Sheffield, , United Kingdom
Dept. of Nephrology, Morriston Hospital
Swansea, , United Kingdom
Countries
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Other Identifiers
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IH 002 (ALCON)
Identifier Type: -
Identifier Source: org_study_id
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