A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
NCT ID: NCT00416520
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
336 participants
INTERVENTIONAL
2007-06-30
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
2
Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
3
Another phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks
Interventions
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MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Another phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Clinically stable haemodialysis or peritoneal dialysis
* Stable phosphate control
* On a stabilised phosphorus diet
* Female and of child-bearing potential have a negative serum pregnancy test.
* Male subjects must agree to use appropriate contraception.
Exclusion Criteria
* Body Mass Index (BMI) \<=16.0 kg/m2 or \>=40.0 kg/m2
* A current or history of significant gastrointestinal motility problems
* A positive test for HIV 1 and 2 antibodies
* A history of substance or alcohol abuse within the last year.
* Seizure disorders
* A history of drug or other allergy
* A temporary catheter as a vascular access
* Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent
18 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Professor
Role: PRINCIPAL_INVESTIGATOR
Information at Mitsubishi Pharma Europe
Locations
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Adelaide, , Australia
Nedlands, , Australia
Parkville, , Australia
St Leonards, , Australia
Sydney, , Australia
Woolloongabba, , Australia
Graz, , Austria
Frýdek-Místek, , Czechia
HradecKralove, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Tábor, , Czechia
Ústí nad Labem, , Czechia
Bordeaux, , France
Montpelier, , France
Paris, , France
Aachen, , Germany
Aschaffenburg, , Germany
Coburg, , Germany
Coesfeld, , Germany
Darmstadt, , Germany
Dieburg, , Germany
Dortmund, , Germany
Düsseldorf, , Germany
Hamburg, , Germany
Homberg (Efze), , Germany
Langen, , Germany
Mannheim-Kafertal, , Germany
München, , Germany
Potsdam-Babelsberg, , Germany
Baja, , Hungary
Budapest, , Hungary
Kisvárda, , Hungary
Veszprém, , Hungary
Biella, , Italy
Como, , Italy
Cremona, , Italy
Lecco, , Italy
Livorno, , Italy
Milan, , Italy
Pavia, , Italy
Perugia, , Italy
Rome, , Italy
Ciechanów, , Poland
Częstochowa, , Poland
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Oświęcim, , Poland
Pabianice, , Poland
Rybnik, , Poland
Sokołów Podlaski, , Poland
Starogard Gdański, , Poland
Warsaw, , Poland
Wejherowo, , Poland
Zgierz, , Poland
Zielona Góra, , Poland
Cape Town, , South Africa
Durban, , South Africa
Gauteng, , South Africa
Johannesburg, , South Africa
Port Elizabeth, , South Africa
Barcelona, , Spain
Oviedo, , Spain
Seville, , Spain
Glasgow, , United Kingdom
Stevenage, , United Kingdom
Countries
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References
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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.
Other Identifiers
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MCI-196-E07
Identifier Type: -
Identifier Source: org_study_id
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