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

Chronic Kidney Failure Clinical Trial

Official title:

A Multicentre Phase II Study With Magnesium Iron Hydroxycarbonate: an Open-label, Dose-ranging Phase Followed by a Placebo-controlled, Double-blind, Parallel-group Comparison in Haemodialysis Subjects With Hyperphosphataemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317694
• Other study ID #: IH 001 (ACT 2)
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2006
• Last updated: July 21, 2009
• Start date: March 2006
• Est. completion date: June 2007

Study information

• Verified date: July 2009
• Source: Ineos Healthcare Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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 blood-vessel disease).

Current guidelines indicate that blood phosphorus levels should be maintained between 1.13 to 1.78 mmol/L in patients who receive hemodialysis.

This study is designed to investigate magnesium iron hydroxycarbonate's ability to lower and control patients' blood phosphate to the recommended levels and compare the average blood phosphate, calcium, calcium-phosphate product, PTH and magnesium concentrations and overall safety with placebo (or "dummy") tablets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Hyperphosphatemia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Fermagate
Film coated tablet 500mg
• Placebo
Oral administration, film coated tablet, 0mg

Locations

Country	Name	City	State
United Kingdom	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 States	Davita Dialysis Center	Charlotte	North Carolina
United States	Southeast Renal Associates	Charlotte	North Carolina
United States	1614 West 42nd Street	Pine Bluff	Arkansas
United States	US Renal Care	Stuttgart	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Ineos Healthcare Limited

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve controlled serum phosphate concentrations during the double-blind comparative phase		Mean of last two serum phosphate values in the double blind phase	No
Secondary	Change from baseline in mean serum phosphate concentration		Mean of last two serum phosphate values	No
Secondary	Change from baseline in serum calcium		Specified visits throughout the study period	Yes
Secondary	Change from baseline calcium-phosphate product		Specified visits throughout the study period	Yes
Secondary	Change from baseline PTH		Specified visits throughout the study period	Yes
Secondary	Change from baseline magnesium		Specified visits throughout the study period	Yes
Secondary	Assessment of adverse events		Throughout the study period	Yes
Secondary	Assessment of routine safety laboratory parameters		Specified visits throughout the study period	Yes
Secondary	Assessment of physical examination		At screen and follow-up	Yes
Secondary	Assessment of 12-lead electrocardiogram		At screen and follow-up	Yes
Secondary	Assessment of bowel habits		Specified visits throughout the study period	Yes