Overview

Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
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 Magnesium iron hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive hemodialysis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ineos Healthcare Limited
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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the subject being withdrawn.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.