Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Kidney Failure
In brief
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.
Key facts
- Study ID
- NCT00317694
- Run by
- Ineos Healthcare Limited
- People needed
- 111
- Starts
- 2006-03-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2009-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn.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 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.
- 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.
Where it is running
- 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 — 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
Full record on ClinicalTrials.gov
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