Bosutinib For Autosomal Dominant Polycystic Kidney Disease
NCT ID: NCT01233869
Last Updated: 2016-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2010-12-31
2014-08-31
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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Cohort A
Bosutinib
Once daily oral dose of 200 mg of bosutinib
Cohort B
Bosutinib
Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
Cohort C
Placebo
Once daily oral dose of placebo
Interventions
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Bosutinib
Once daily oral dose of 200 mg of bosutinib
Bosutinib
Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
Placebo
Once daily oral dose of placebo
Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).
* Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI.
Exclusion Criteria
* Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg).
* Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies.
18 Years
50 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Southwest Kidney Institute, PLC
Phoenix, Arizona, United States
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States
Southwest Kidney Institute, PLC
Tempe, Arizona, United States
Capital Nephrology Clinical Research
Sacramento, California, United States
Boise Kidney & Hypertension Institute, PLLC
Caldwell, Idaho, United States
Boise Kidney & Hypertension Institute, PLLC
Meridian, Idaho, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
New York University - HHC CTSI Clinical Research Center
New York, New York, United States
Doylestown Hospital MRI
Doylestown, Pennsylvania, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Nephrology/Hypertension Specialists
Doylestown, Pennsylvania, United States
Renal Associates, PA
San Antonio, Texas, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, United States
University of Virginia Health System - Nephrology
Charlottesville, Virginia, United States
University of Virginia Health System
Charlottesville, Virginia, United States
The Polyclinic
Seattle, Washington, United States
Renal Remission and Hypertension Clinic
Silverdale, Washington, United States
Monash Medical Centre
Clayton, Victoria, Australia
Toronto General Hospital
Toronto, Ontario, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Klinika gerontologicka a metabolicka
Hradec Králové, , Czechia
Krajska nemocnice Liberec
Liberec, , Czechia
Nemocnice Nove Mesto na Morave
Nové Město na Moravě, , Czechia
Fakultni poliklinika VFN
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Pharmaceutical Research Associates CZ, s.r.o.
Prague, , Czechia
PRA Magyarorszag Kft. Klinikai Farmakologiai Vizsgalohely
Budapest, , Hungary
Fovarosi Onkormanyzat Szent Imre Korhaz BSZMI Klinikai Farmakologiai Reszlege
Budapest, , Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont I.sz.Belgyogyaszati Klinika
Szeged, , Hungary
Istituti Ospitalieri di Cremona
Cremona, , Italy
A.O. Universitaria Ospedali Riuniti di Foggia
Foggia, , Italy
Vilnius University Hospital Santariskiu Clinic, Public Institution, Centre of Nephrology
Vilnius, , Lithuania
Spitalul Clinic Republican
Chisinau, , Moldova
Zaklad Diagnostyki Chorob Serca, II Katedra Kardiologii
Gdansk, , Poland
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
Gdansk, , Poland
Specjalistyczny Szpital Zachodni im. Jana Pawla II w Grodzisku Mazowieckim
Grodzisk Mazowiecki, , Poland
Krakowskie Centrum Medyczne NZOZ
Krakow, , Poland
Klinika Nefrologii, Hipertensjologii i Chorob Wewnetrznych Katedry Chorob Wewnetrznych UWM
Olsztyn, , Poland
Pracownia Echokardiografii, Oddzial Kardiologii
Olsztyn, , Poland
Centrum Medyczne Aesculap
Radom, , Poland
Klinika Kardiologii
Szczecin, , Poland
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
Szczecin, , Poland
Szpital Powiatowy w Wolominie
Wołomin, , Poland
SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
Wroclaw, , Poland
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea
Oradea, Jud. Bihor, Romania
Spitalul Clinic Dr. C. I. Parhon Iasi
Iași, Jud. Iasi, Romania
Institutul Clinic Fundeni, Centrul de Medicina Interna-Nefrologie
Bucharest, , Romania
SPITALUL CLINIC JUDETEAN DE URGENTA TIMISOARA ,Clinica de Nefrologie
Timișoara, , Romania
Univerzitna nemocnica Bratislava
Limbova 5, Bratislava Region, Slovakia
SUMMIT CLINICAL RESEARCH, s.r.o., Oddelenie internej mediciny a klinickej farmakologie
Bratislava, , Slovakia
Seoul National University Hospital, Department of Internal Medicine
Seoul, , South Korea
Samsung Medical Center/Division of Nephrology
Seoul, , South Korea
Eulji General Hospital
Seoul, , South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, , Spain
Sahlgrenska Universitetssjukhuset, Njurmedicin
Gothenburg, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Universitaetsspital Zuerich
Zurich, , Switzerland
Istanbul University, Istanbul Tip Fakultesi
Istanbul, Capa, Turkey (Türkiye)
Dokuz Eylul Universitesi Hastanesi Ic Hastaliklari Anabilim Dali
Izmir, Inciralti/ Narlidere, Turkey (Türkiye)
Morriston Hospital
Swansea, Wales, United Kingdom
BHF Glasgow Cardiovascular Research Centre, University of Glasgow
Glasgow, , United Kingdom
Renal and Urology Directorate, Leicester General Hospital
Leicester, , United Kingdom
Countries
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References
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St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
Tesar V, Ciechanowski K, Pei Y, Barash I, Shannon M, Li R, Williams JH, Levisetti M, Arkin S, Serra A. Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2017 Nov;28(11):3404-3413. doi: 10.1681/ASN.2016111232. Epub 2017 Aug 24.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3160A7-2211
Identifier Type: OTHER
Identifier Source: secondary_id
2010-023017-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1871019
Identifier Type: -
Identifier Source: org_study_id
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