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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00317694
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : August 10, 2009
Information provided by:
Ineos Healthcare Limited

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 Magnesium iron hydroxycarbonate is in controlling levels of phosphate in the blood in patients who receive hemodialysis.

Condition or disease Intervention/treatment Phase
Chronic Kidney Failure Drug: Fermagate Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Fermagate
Film coated tablet 500mg
Other Name: Magnesium iron hydroxycarbonate
Placebo Comparator: 2 Drug: Placebo
Oral administration, film coated tablet, 0mg

Primary Outcome Measures :
  1. Proportion of subjects who achieve controlled serum phosphate concentrations during the double-blind comparative phase [ Time Frame: Mean of last two serum phosphate values in the double blind phase ]

Secondary Outcome Measures :
  1. Change from baseline in mean serum phosphate concentration [ Time Frame: Mean of last two serum phosphate values ]
  2. Change from baseline in serum calcium [ Time Frame: Specified visits throughout the study period ]
  3. Change from baseline calcium-phosphate product [ Time Frame: Specified visits throughout the study period ]
  4. Change from baseline PTH [ Time Frame: Specified visits throughout the study period ]
  5. Change from baseline magnesium [ Time Frame: Specified visits throughout the study period ]
  6. Assessment of adverse events [ Time Frame: Throughout the study period ]
  7. Assessment of routine safety laboratory parameters [ Time Frame: Specified visits throughout the study period ]
  8. Assessment of physical examination [ Time Frame: At screen and follow-up ]
  9. Assessment of 12-lead electrocardiogram [ Time Frame: At screen and follow-up ]
  10. Assessment of bowel habits [ Time Frame: Specified visits throughout the study period ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00317694

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

Responsible Party: Chief Medical Officer, Ineos Healthcare Ltd. Identifier: NCT00317694     History of Changes
Other Study ID Numbers: IH 001 (ACT 2)
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: August 10, 2009
Last Verified: July 2009

Keywords provided by Ineos Healthcare Limited:
Phosphate binder

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic