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Sponsored by: |
Mitsubishi Tanabe Pharma Corporation |
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Information provided by: | Mitsubishi Tanabe Pharma Corporation |
ClinicalTrials.gov Identifier: | NCT00451295 |
This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.
Condition | Intervention | Phase |
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Chronic Kidney Disease Dialysis Hyperphosphatemia |
Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia. |
Estimated Enrollment: | 200 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
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2: Experimental |
Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Information at Mitsubishi Pharama Europe | information@mitsubishi-pharma.eu |
Czech Republic | |
Recruiting | |
Ostrava, Czech Republic | |
Recruiting | |
Frydek-Mistek, Czech Republic | |
France | |
Recruiting | |
Bordeaux, France | |
Recruiting | |
Montpelier, France | |
Germany | |
Recruiting | |
Coburg, Germany | |
Recruiting | |
Aachen, Germany | |
Italy | |
Recruiting | |
Lecco, Italy | |
Recruiting | |
Pavia, Italy | |
Recruiting | |
Milan, Italy | |
Macedonia, The Former Yugoslav Republic of | |
Recruiting | |
Skopje, Macedonia, The Former Yugoslav Republic of | |
Poland | |
Recruiting | |
Krakow, Poland | |
Recruiting | |
Lodz, Poland | |
Recruiting | |
Gdansk, Poland | |
Recruiting | |
Oswiecim, Poland | |
Recruiting | |
Wejherowo, Poland | |
Recruiting | |
Wroclaw, Poland | |
Recruiting | |
Poznan, Poland | |
Serbia | |
Recruiting | |
Belgrade, Serbia | |
Recruiting | |
Nis, Serbia | |
Recruiting | |
Novisad, Serbia | |
South Africa | |
Recruiting | |
Cape Town, South Africa | |
Recruiting | |
Gauteng, South Africa | |
Spain | |
Recruiting | |
Oviedo, Spain | |
Recruiting | |
Barcelona, Spain | |
United Kingdom | |
Recruiting | |
STEVENAGE, United Kingdom |
Principal Investigator: | Professor | Information at Mitsubishi Pharma Europe |
Responsible Party: | Mitsubishi Tanabe Pharma Corporation ( Study Project Manager ) |
Study ID Numbers: | MCI-196-E09 |
Study First Received: | March 22, 2007 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00451295 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: State Institute for Drug Control; Italy: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Germany: Federal Institute for Drugs and Medical Devices; South Africa: Medicines Control Council; Spain: Ministry of Health and Consumption |
Chronic Kidney Disease Dialysis Hyperphosphatemia |
Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Hyperphosphatemia Kidney Diseases Metabolic Disorder Kidney Failure |
Phosphorus Metabolism Disorders Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Hyperphosphatemia Kidney Diseases Kidney Failure |