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

Sponsored by:	Ineos Healthcare Limited
Information provided by:	Ineos Healthcare Limited
ClinicalTrials.gov Identifier:	NCT00317694

Purpose

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	Intervention	Phase
Chronic Kidney Failure	Drug: Fermagate Drug: Placebo	Phase II

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Ineos Healthcare Limited:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean serum phosphate concentration [ Time Frame: Mean of last two serum phosphate values ] [ Designated as safety issue: No ]
Change from baseline in serum calcium [ Time Frame: Specified visits throughout the study period ] [ Designated as safety issue: Yes ]
Change from baseline calcium-phosphate product [ Time Frame: Specified visits throughout the study period ] [ Designated as safety issue: Yes ]
Change from baseline PTH [ Time Frame: Specified visits throughout the study period ] [ Designated as safety issue: Yes ]
Change from baseline magnesium [ Time Frame: Specified visits throughout the study period ] [ Designated as safety issue: Yes ]
Assessment of adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]
Assessment of routine safety laboratory parameters [ Time Frame: Specified visits throughout the study period ] [ Designated as safety issue: Yes ]
Assessment of physical examination [ Time Frame: At screen and follow-up ] [ Designated as safety issue: Yes ]
Assessment of 12-lead electrocardiogram [ Time Frame: At screen and follow-up ] [ Designated as safety issue: Yes ]
Assessment of bowel habits [ Time Frame: Specified visits throughout the study period ] [ Designated as safety issue: Yes ]

Enrollment:	111
Study Start Date:	March 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Fermagate Film coated tablet 500mg
2: Placebo Comparator	Drug: Placebo Oral administration, film coated tablet, 0mg

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317694

Locations

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
Nottingham Renal and Transplant Unit, Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
General Medicine and Nephrology, Norfolk and Norwich University Hospital
Norwich, United Kingdom, NR4 7RF
Dialysis Unit, Broad Green Hospital
Liverpool, United Kingdom, L14 3LB
Dept. of Nephrology, Morriston Hospital
Swansea, United Kingdom, SA6 6NL
Addenbrookes Dialysis Centre, Addenbrookes Hospital
Cambridge, United Kingdom, CB2 2QQ
Renal Unit, Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Sheffield Kidney Unit, Northern General Hospital
Sheffield, United Kingdom, S5 7AU
Richard Bright Renal Unit, Southmead Hospital
Bristol, United Kingdom, BS10 5NB
St Lukes Hospital
Bradford, United Kingdom, BD5 0NA
Renal Unit, Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS

Sponsors and Collaborators

Ineos Healthcare Limited

Investigators

Principal Investigator:

Simon Roe, MB ChB

Nottingham Renal and Transplant Unit, Nottingham City Hospital

More Information

No publications provided

Responsible Party:	Ineos Healthcare Ltd. ( Chief Medical Officer )
Study ID Numbers:	IH 001 (ACT 2)
Study First Received:	April 21, 2006
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00317694 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ineos Healthcare Limited:

Hyperphosphatemia
Phosphate binder

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Hyperphosphatemia
Kidney Diseases
Iron
Metabolic Disorder
Kidney Failure

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Hyperphosphatemia
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009