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| Sponsor: | Ineos Healthcare Limited |
|---|---|
| Information provided by: | Ineos Healthcare Limited |
| ClinicalTrials.gov Identifier: | NCT00841126 |
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 is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Failure |
Drug: Magnesium iron hydroxycarbonate Drug: Lanthanum carbonate Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open, Randomized, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate Together With a Randomized Placebo Controlled Double Blind Fermagate Comparison in Hemodialysis Patients With Hyperphosphatemia |
| Estimated Enrollment: | 657 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Magnesium iron hydroxycarbonate |
Drug: Magnesium iron hydroxycarbonate
500 mg tablets, administered orally: initial dosage 500 or 1000 mg (total daily dose 1500 or 3000 mg) depending on serum phosphate concentration, titrated to a maximum DAILY dose of 9000 mg). The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 3000 mg.
Other Name: Alpharen, magnesium iron hydroxycarbonate
|
| Active Comparator: Lanthanum carbonate |
Drug: Lanthanum carbonate
750 mg chewable tablets, administered orally: initial dosage 750 mg up to 3-times daily (total daily dose 2250 mg), titrated to a maximum SINGLE dose of 1500 mg (DAILY dose 3750 mg). The total daily dose should be divided and taken with meals.
Other Name: Fosrenol
|
| Placebo Comparator: Placebo |
Drug: Placebo
0 mg (500 mg-size) tablets, administered orally: The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 6 tablets.
Other Name: Placebo
|
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 deposites in the body and blood-vessel disease.
Current guidelines indicate that blood phosphorous levels should be maintained between 1.13 to 1.78 mmol/L in patients who receive hemodialysis.
This is a 2-stage re-randomization design where Stage 1 is a randomized, open label comparison between fermagate and lanthanum carbonate (in a non-inferiority design) and Stage 2 is a randomized double blind comparison between fermagate and placebo (in a superiority design).
Objectives at Stage 1:
Primary Objective:
The primary objective is to establish the efficacy of fermagate by demonstrating the noninferiority (with possible assessment of superiority) of fermagate to lanthanum carbonate in lowering serum phosphate in hemodialysis patients.
Secondary objectives:
The secondary objectives are to:
Objectives at Stage 2:
Stage 2 will use patients who complete the 3-month maintenance period of Stage 1 and who were originally randomized to fermagate.
Primary Objective:
The primary objective is to establish efficacy of fermagate by demonstrating the superiority of fermagate over placebo in lowering serum phosphate in hemodialysis patients.
Secondary objectives:
The secondary objectives are to:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Subjects will be considered eligible for entry in the study if they meet all of the following criteria.
If required to take >6000 mg/day of fermagate, the subject will be willing to have at least three meals per day.
Specifically, for randomization and inclusion into the treatment period, one of the following criteria must be fulfilled:
Exclusion:
Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria.
The above inclusion and exclusion criteria would be the same for all countries except the exclusion criteria of the QTc interval would be different for Germany (QTc interval of >470ms at screen).
Contacts and Locations
Show 112 Study Locations| Study Chair: | Information at Ineos Healthcare Limited (Chief Medical Officer) | INEOS Healthcare Ltd, UK |
More Information
| Responsible Party: | Chief Medical Officer, INEOS Healthcare Limited |
| ClinicalTrials.gov Identifier: | NCT00841126 History of Changes |
| Other Study ID Numbers: | ACT 401, 2008-004729-41 |
| Study First Received: | February 10, 2009 |
| Last Updated: | October 18, 2010 |
| Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; South Africa: Medicines Control Council; Canada: Health Canada; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Germany: Federal Institute for Drugs and Medical Devices; Brazil: National Health Surveillance Agency; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Malta: Medicines Authority; New Zealand: Medsafe |
|
Hyperphosphatemia Phosphate binder |
|
Kidney Failure, Chronic Renal Insufficiency Hyperphosphatemia Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Phosphorus Metabolism Disorders |
Metabolic Diseases Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |