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: Magnesium iron hydroxycarbonate	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, 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

Secondary Outcome Measures:

Change from baseline in mean serum phosphate concentration
Change from baseline in serum calcium
Change from baseline calcium-phosphate product
Change from baseline PTH
Change from baseline magnesium
Assessment of adverse events
Assessment of routine safety laboratory parameters
Assessment of physical examination
Assessment of 12-lead electrocardiogram
Assessment of bowel habits

Estimated Enrollment:	160
Study Start Date:	March 2006
Study Completion Date:	June 2007

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 hemodialysis, aged 18 years or over
On a stable hemodialysis regimen (three times per week) for at least 3 months
On a stable dose of a phosphate binder for at least 1 month prior to screening

Exclusion Criteria:

A history of a motility disorder of the intestines
Taking medication for seizures
A history of hemochromatosis
A history of high serum ferritin concentration
A history of dysphagia or swallowing disorders
Current haemoglobin concentration of < 10.00 g/dL

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

More Information

Study ID Numbers:	IH 001 (ACT 2)
Study First Received:	April 21, 2006
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00317694
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
Metabolic disorder
Iron
Kidney Failure

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009