Study Stopped
Limited number of subjects
An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
ALCON
A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
1 other identifier
interventional
44
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2006
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 31, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedAugust 10, 2009
July 1, 2009
1.8 years
July 31, 2006
July 21, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of AEs and other safety parameters
88 weeks
Secondary Outcomes (1)
Assessment of serum phosphate concentrations
88 weeks
Study Arms (1)
Fermagate
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
1614 West 42nd Street
Pine Bluff, Arkansas, 71603, United States
US Renal Care
Stuttgart, Arkansas, 72160, United States
Davita Dialysis Center
Charlotte, North Carolina, 28208, United States
Southeast Renal Associates
Charlotte, North Carolina, 28208, United States
Renal Unit, Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
St Lukes Hospital, Little Horton Lane
Bradford, BD5 0NA, United Kingdom
Richard Bright Renal Unit, Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Addenbrookes Dialysis Centre, Addenbrookes Hospital
Cambridge, CB2 2QQ, United Kingdom
Renal Unit, Leicester General Hospital
Leicester, LE5 4PW, United Kingdom
Dialysis Unit, Broad Green Hospital
Liverpool, L14 3LB, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
General Medicine and Nephrology, Norfolk and Norwich University Hospital
Norwich, NR4 7RF, United Kingdom
Nottingham Renal and Transplant Unit, Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Sheffield Kidney Unit, Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Dept. of Nephrology, Morriston Hospital
Swansea, SA6 6NL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Roe, MB ChB
Nottingham City Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 31, 2006
First Posted
August 1, 2006
Study Start
July 1, 2006
Primary Completion
May 1, 2008
Study Completion
June 1, 2008
Last Updated
August 10, 2009
Record last verified: 2009-07