Status:
COMPLETED
Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
Lead Sponsor:
Ineos Healthcare Limited
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Ma...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn.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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00317694
Start Date
March 1 2006
End Date
June 1 2007
Last Update
August 10 2009
Active Locations (15)
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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