A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

PHASE3CompletedINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Chronic Kidney DiseaseHyperphosphatemia
Interventions
DRUG

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

DRUG

Placebo

3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

DRUG

Another phosphate binder (Sevelamer)

Current approved dosing recommendations for 12 weeks

Trial Locations (68)

Unknown

Adelaide

Nedlands

Parkville

St Leonards

Sydney

Woolloongabba

Graz

Frýdek-Místek

HradecKralove

Ostrava

Prague

Tábor

Ústí nad Labem

Bordeaux

Montpelier

Paris

Aachen

Aschaffenburg

Coburg

Coesfeld

Darmstadt

Dieburg

Dortmund

Düsseldorf

Hamburg

Homberg (Efze)

Langen

Mannheim-Kafertal

München

Potsdam-Babelsberg

Baja

Budapest

Kisvárda

Veszprém

Biella

Como

Cremona

Lecco

Livorno

Milan

Pavia

Perugia

Rome

Ciechanów

Częstochowa

Gdansk

Krakow

Lodz

Lublin

Oświęcim

Pabianice

Rybnik

Sokołów Podlaski

Starogard Gdański

Warsaw

Wejherowo

Zgierz

Zielona Góra

Cape Town

Durban

Gauteng

Johannesburg

Port Elizabeth

Barcelona

Oviedo

Seville

Glasgow

Stevenage

All Listed Sponsors
lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY