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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Failure
• Intervention / Treatment: Drug: Fermagate; Drug: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Renal Unit, Birmingham Heartlands Hospital
  • Bradford, United Kingdom, BD5 0NA
    • St Lukes Hospital
  • Bristol, United Kingdom, BS10 5NB
    • Richard Bright Renal Unit, Southmead Hospital
  • Cambridge, United Kingdom, CB2 2QQ
    • Addenbrookes Dialysis Centre, Addenbrookes Hospital
  • Leicester, United Kingdom, LE5 4PW
    • Renal Unit, Leicester General Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital
  • Liverpool, United Kingdom, L14 3LB
    • Dialysis Unit, Broad Green Hospital
  • Norwich, United Kingdom, NR4 7RF
    • General Medicine and Nephrology, Norfolk and Norwich University Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham Renal and Transplant Unit, Nottingham City Hospital
  • Sheffield, United Kingdom, S5 7AU
    • Sheffield Kidney Unit, Northern General Hospital
  • Swansea, United Kingdom, SA6 6NL
    • Dept. of Nephrology, Morriston Hospital
• United States
  • Arkansas
    • Pine Bluff, Arkansas, United States, 71603
      • 1614 West 42nd Street
    • Stuttgart, Arkansas, United States, 72160
      • US Renal Care
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Davita Dialysis Center
    • Charlotte, North Carolina, United States, 28208
      • Southeast Renal Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Fermagate; Film coated tablet 500mg; Other Names: Magnesium iron hydroxycarbonate
Placebo Comparator: 2	Drug: Placebo; Oral administration, film coated tablet, 0mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in mean serum phosphate concentration	Mean of last two serum phosphate values
Change from baseline in serum calcium	Specified visits throughout the study period
Change from baseline calcium-phosphate product	Specified visits throughout the study period
Change from baseline PTH	Specified visits throughout the study period
Change from baseline magnesium	Specified visits throughout the study period
Assessment of adverse events	Throughout the study period
Assessment of routine safety laboratory parameters	Specified visits throughout the study period
Assessment of physical examination	At screen and follow-up
Assessment of 12-lead electrocardiogram	At screen and follow-up
Assessment of bowel habits	Specified visits throughout the study period

Collaborators and Investigators

• Sponsor: Ineos Healthcare Limited
• Investigators: Principal Investigator: Simon Roe, MB ChB, Nottingham Renal and Transplant Unit, Nottingham City Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: April 21, 2006
• First Submitted That Met QC Criteria: April 21, 2006
• First Posted (Estimate): April 25, 2006

Study Record Updates

• Last Update Posted (Estimate): August 10, 2009
• Last Update Submitted That Met QC Criteria: July 21, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Hyperphosphatemia; Phosphate binder
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Phosphorus Metabolism Disorders; Kidney Failure, Chronic; Renal Insufficiency; Hyperphosphatemia
• Other Study ID Numbers: IH 001 (ACT 2)