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
1 other identifier
interventional
111
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2006
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 21, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedAugust 10, 2009
July 1, 2009
1.3 years
April 21, 2006
July 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
1614 West 42nd Street
Pine Bluff, Arkansas, 71603, United States
US Renal Care
Stuttgart, Arkansas, 72160, United States
Davita Dialysis Center
Charlotte, North Carolina, 28208, United States
Southeast Renal Associates
Charlotte, North Carolina, 28208, United States
Renal Unit, Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
St Lukes Hospital
Bradford, BD5 0NA, United Kingdom
Richard Bright Renal Unit, Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Addenbrookes Dialysis Centre, Addenbrookes Hospital
Cambridge, CB2 2QQ, United Kingdom
Renal Unit, Leicester General Hospital
Leicester, LE5 4PW, United Kingdom
Dialysis Unit, Broad Green Hospital
Liverpool, L14 3LB, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
General Medicine and Nephrology, Norfolk and Norwich University Hospital
Norwich, NR4 7RF, United Kingdom
Nottingham Renal and Transplant Unit, Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Sheffield Kidney Unit, Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Dept. of Nephrology, Morriston Hospital
Swansea, SA6 6NL, United Kingdom
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Roe, MB ChB
Nottingham Renal and Transplant Unit, Nottingham City Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 21, 2006
First Posted
April 25, 2006
Study Start
March 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
August 10, 2009
Record last verified: 2009-07