Trial record 1 of 1 for:    Bosutinib for ADPKD
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Bosutinib For Autosomal Dominant Polycystic Kidney Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01233869
First received: October 28, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.


Condition Intervention Phase
Polycystic Kidney, Autosomal Dominant
Drug: Bosutinib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Annualized rate (%) of kidney enlargement relative to placebo [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety endpoints to include incidence of AEs and SAEs, changes in laboratory test results, including ECGs, and changes in vital signs [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of treatment with bosutinib on renal function evaluations including blood urea nitrogen and serum and urine creatinine. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to first occurence (or worsening) of clinical measures of disease activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Serum concentrations of bosutinib will be measured, PK parameters (Cmax, Tmax, AUCt, Cl/F, Vz/F, t1/2 and R) will be calculated [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Subject-reported, disease specific quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: December 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A Drug: Bosutinib
Once daily oral dose of 200 mg of bosutinib
Experimental: Cohort B Drug: Bosutinib
Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
Placebo Comparator: Cohort C Drug: Placebo
Once daily oral dose of placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 to 50 years old at the time of consent.
  • Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).
  • Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI.

Exclusion Criteria:

  • eGFR < 60 mL/min/1.73m2.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233869

  Hide Study Locations
Locations
United States, Arizona
Southwest Kidney Institute, PLC
Phoenix, Arizona, United States, 85004
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States, 85284
Southwest Kidney Institute, PLC
Tempe, Arizona, United States, 85284
United States, California
Capital Nephrology Clinical Research
Sacramento, California, United States, 95825
United States, Idaho
Boise Kidney & Hypertension Institute, PLLC
Caldwell, Idaho, United States, 83605
Boise Kidney & Hypertension Institute, PLLC
Meridian, Idaho, United States, 83642
United States, Louisiana
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
New York University - HHC CTSI Clinical Research Center
New York, New York, United States, 10016
United States, Pennsylvania
Nephrology/Hypertension Specialists
Doylestown, Pennsylvania, United States, 18901
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
Doylestown Hospital MRI
Doylestown, Pennsylvania, United States, 18901
United States, Texas
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, United States, 78229
South Texas Radiology Imaging Centers (Imaging Only)
San Antonio, Texas, United States, 78229
Renal Associates, PA
San Antonio, Texas, United States, 78215
United States, Virginia
University of Virginia Health System - Nephrology
Charlottesville, Virginia, United States, 22908
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
The Polyclinic
Seattle, Washington, United States, 98104
Renal Remission and Hypertension Clinic
Silverdale, Washington, United States, 98383
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Czech Republic
Klinika gerontologicka a metabolicka
Hradec Kralove, Czech Republic, 500 05
Krajska nemocnice Liberec
Liberec 1, Czech Republic, 460 63
Nemocnice Nove Mesto na Morave
Nove Mesto na Morave, Czech Republic, 592 31
Fakultni poliklinika VFN
Praha 2, Czech Republic, 128 00
Vseobecna fakultni nemocnice v Praze
Praha 2, Czech Republic, 128 08
Pharmaceutical Research Associates CZ, s.r.o.
Praha 7, Czech Republic, 170 00
Hungary
Fovarosi Onkormanyzat Szent Imre Korhaz BSZMI Klinikai Farmakologiai Reszlege
Budapest, Hungary, 1115
PRA Magyarorszag Kft. Klinikai Farmakologiai Vizsgalohely
Budapest, Hungary, 1077
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont I.sz.Belgyogyaszati Klinika
Szeged, Hungary, 6720
Italy
Istituti Ospitalieri di Cremona
Cremona, Italy, 26100
A.O. Universitaria Ospedali Riuniti di Foggia
Foggia, Italy, 71100
Korea, Republic of
Seoul Eulji Hospital, Department of Internal Medicine, Division of Nephrology
Seoul, Korea, Republic of, 139-872
Samsung Medical Center/Division of Nephrology
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital, Department of Internal Medicine
Seoul, Korea, Republic of, 110-744
Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution, Centre of Nephrology
Vilnius, Lithuania, 08661
Moldova, Republic of
Spitalul Clinic Republican
Chisinau, Moldova, Republic of, 2025
Poland
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
Gdansk, Poland, 80-952
Zaklad Diagnostyki Chorob Serca, II Katedra Kardiologii
Gdansk, Poland, 80-210
Specjalistyczny Szpital Zachodni im. Jana Pawla II w Grodzisku Mazowieckim
Grodzisk Mazowiecki, Poland, 05-825
NZOZ Diagnostyka Laboratorium o/Krakow
Krakow, Poland, 31-513
Krakowskie Centrum Medyczne NZOZ
Krakow, Poland, 31-501
Klinika Nefrologii, Hipertensjologii i Chorob Wewnetrznych Katedry Chorob Wewnetrznych UWM
Olsztyn, Poland, 10-561
Oddzial Gastroenterologiczny
Olsztyn, Poland
Pracownia Echokardiografii, Oddzial Kardiologii
Olsztyn, Poland, 10-561
Centrum Medyczne Aesculap
Radom, Poland, 26-600
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
Szczecin, Poland, 70-111
Klinika Kardiologii
Szczecin, Poland, 70-111
Szpital Powiatowy w Wolominie
Wolomin, Poland, 05-200
SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
Wroclaw, Poland, 50-556
Romania
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea
Oradea, jud. Bihor, Romania, 410469
Spitalul Clinic Dr. C. I. Parhon Iasi
Iasi, jud. Iasi, Romania, 700503
Institutul Clinic Fundeni, Centrul de Medicina Interna-Nefrologie
Bucuresti, Romania, 022328
SPITALUL CLINIC JUDETEAN DE URGENTA TIMISOARA ,Clinica de Nefrologie
Timisoara, Romania, 300736
Slovakia
SUMMIT CLINICAL RESEARCH, s.r.o., Oddelenie internej mediciny a klinickej farmakologie
Bratislava, Slovakia, 831 01
Spain
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Sweden
Sahlgrenska Universitetssjukhuset, Njurmedicin
Goteborg, Sweden, 413 45
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 171 76
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 141 86
Switzerland
Universitaetsspital Zuerich
Zuerich, Switzerland, 8091
Turkey
Istanbul University, Istanbul Tip Fakultesi
Istanbul, Capa, Turkey, 34390
Dokuz Eylul Universitesi Hastanesi Ic Hastaliklari Anabilim Dali
Izmir, Inciralti/ Narlidere, Turkey, 35340
United Kingdom
Morriston Hospital
Swansea, Wales, United Kingdom, SA6 6NL
BHF Glasgow Cardiovascular Research Centre, University of Glasgow
Glasgow, United Kingdom, G12 8TA
Renal and Urology Directorate, Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01233869     History of Changes
Other Study ID Numbers: B1871019, 3160A7-2211
Study First Received: October 28, 2010
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bosutinib
Autosomal Dominant Polycystic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on April 17, 2014