Clinical trial NCT00317694: Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Failure
Keywords: Hyperphosphatemia
Phosphate binder
Lead sponsor: Ineos Healthcare Limited
Sponsor class: INDUSTRY
First posted: 2006-04-25
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Proportion of subjects who achieve controlled serum phosphate concentrations during the double-blind comparative phase
timeFrame: Mean of last two serum phosphate values in the double blind phase
Secondary outcomes:
measure: Change from baseline in mean serum phosphate concentration
timeFrame: Mean of last two serum phosphate values
measure: Change from baseline in serum calcium
timeFrame: Specified visits throughout the study period
measure: Change from baseline calcium-phosphate product
timeFrame: Specified visits throughout the study period
measure: Change from baseline PTH
timeFrame: Specified visits throughout the study period
measure: Change from baseline magnesium
timeFrame: Specified visits throughout the study period
measure: Assessment of adverse events
timeFrame: Throughout the study period
measure: Assessment of routine safety laboratory parameters
timeFrame: Specified visits throughout the study period
measure: Assessment of physical examination
timeFrame: At screen and follow-up
measure: Assessment of 12-lead electrocardiogram
timeFrame: At screen and follow-up
measure: Assessment of bowel habits
timeFrame: Specified visits throughout the study period
Other outcomes:
Locations:
city: Pine Bluff
country: United States
facility: 1614 West 42nd Street
state: Arkansas
city: Stuttgart
country: United States
facility: US Renal Care
state: Arkansas
city: Charlotte
country: United States
facility: Davita Dialysis Center
state: North Carolina
city: Charlotte
country: United States
facility: Southeast Renal Associates
state: North Carolina
city: Birmingham
country: United Kingdom
facility: Renal Unit, Birmingham Heartlands Hospital
city: Bradford
country: United Kingdom
facility: St Lukes Hospital
city: Bristol
country: United Kingdom
facility: Richard Bright Renal Unit, Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Dialysis Centre, Addenbrookes Hospital
city: Leicester
country: United Kingdom
facility: Renal Unit, Leicester General Hospital
city: Liverpool
country: United Kingdom
facility: Dialysis Unit, Broad Green Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Norwich
country: United Kingdom
facility: General Medicine and Nephrology, Norfolk and Norwich University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Renal and Transplant Unit, Nottingham City Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Kidney Unit, Northern General Hospital
city: Swansea
country: United Kingdom
facility: Dept. of Nephrology, Morriston Hospital
Study officials:
affiliation: Nottingham Renal and Transplant Unit, Nottingham City Hospital
name: Simon Roe, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: