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Sponsored by: |
Ineos Healthcare Limited |
---|---|
Information provided by: | Ineos Healthcare Limited |
ClinicalTrials.gov Identifier: | NCT00844662 |
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 haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Failure |
Drug: Fermagate Drug: Sevelamer hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open, Randomised, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride in Haemodialysis Patients With Hyperphosphataemia |
Estimated Enrollment: | 1000 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Fermagate
Film coated tablet 500mg
|
2: Active Comparator |
Drug: Sevelamer hydrochloride
Tablet 800mg
|
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 1.78mmol/L in patients who receive haemodialysis.
The purpose of this study is to establish the non-inferiority of magnesium iron hydroxycarbonate to sevelamer hydrochloride in lowering serum phosphate in haemodialysis patients treated for 3 months. Additional objectives:
(1) to determine the safety of magnesium iron hydroxycarbonate after short term (3 months) and long term (6 and 12 months) treatment, (2)to determine the efficacy of magnesium iron hydroxycarbonate after long term treatment (6 and 12 months) and (3) To compare the effects of magnesium iron hydroxycarbonate and sevelamer hydrochloride on measures of mineral metabolism, albumin, pre-albumin and iron status after short term (3 months) and long term (6 and 12 months) treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 randomisation and inclusion into the treatment period, the following criterion must be fulfilled:
Exclusion Criteria:
Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria.
Contact: Information at Ineos Healthcare Limited (Study Project Manager) | +44 1925 416200 | info@ineoshealthcare.com |
Study Chair: | Chief Medical Officer (Information at Ineos Healthcare Limited), Dr. | Ineos Healthcare Limited |
Responsible Party: | INEOS Healthcare Limited ( Study Project Manager ) |
Study ID Numbers: | ACT 402 |
Study First Received: | February 13, 2009 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00844662 History of Changes |
Health Authority: | United States: Food and Drug Administration; Czech Republic: State Institute for Drug Control; South Africa: Medicines Control Council; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Italy: The Italian Medicines Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Bulgaria: Bulgarian Drug Agency; Estonia: The State Agency of Medicine; Hungary: National Institute of Pharmacy; Lithuania: State Medicine Control Agency - Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Slovakia: State Institute for Drug Control; Mexico: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Hyperphosphataemia phosphate binder |
Sevelamer Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Hyperphosphatemia Chelating Agents Kidney Diseases Metabolic Disorder Kidney Failure |
Phosphorus Metabolism Disorders Renal Insufficiency Metabolic Diseases Molecular Mechanisms of Pharmacological Action Kidney Failure, Chronic Hyperphosphatemia Pharmacologic Actions |
Sevelamer Urologic Diseases Renal Insufficiency, Chronic Kidney Diseases Chelating Agents Kidney Failure |