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Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Primary Purpose

Polycystic Kidney, Autosomal Dominant

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bosutinib
Bosutinib
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Kidney, Autosomal Dominant focused on measuring Bosutinib, Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest Kidney Institute, PLC
  • Southwest Clinical Research Institute, LLC
  • Southwest Kidney Institute, PLC
  • Capital Nephrology Clinical Research
  • Boise Kidney & Hypertension Institute, PLLC
  • Boise Kidney & Hypertension Institute, PLLC
  • Renal Associates of Baton Rouge
  • Tufts Medical Center
  • Washington University School of Medicine
  • Washington University
  • New York University - HHC CTSI Clinical Research Center
  • Doylestown Hospital MRI
  • Doylestown Hospital
  • Nephrology/Hypertension Specialists
  • Renal Associates, PA
  • San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
  • University of Virginia Health System - Nephrology
  • University of Virginia Health System
  • The Polyclinic
  • Renal Remission and Hypertension Clinic
  • Monash Medical Centre
  • Toronto General Hospital
  • Hopital du Sacre-Coeur de Montreal
  • Klinika gerontologicka a metabolicka
  • Krajska nemocnice Liberec
  • Nemocnice Nove Mesto na Morave
  • Fakultni poliklinika VFN
  • Vseobecna fakultni nemocnice v Praze
  • Pharmaceutical Research Associates CZ, s.r.o.
  • PRA Magyarorszag Kft. Klinikai Farmakologiai Vizsgalohely
  • Fovarosi Onkormanyzat Szent Imre Korhaz BSZMI Klinikai Farmakologiai Reszlege
  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont I.sz.Belgyogyaszati Klinika
  • Istituti Ospitalieri di Cremona
  • A.O. Universitaria Ospedali Riuniti di Foggia
  • Seoul National University Hospital, Department of Internal Medicine
  • Samsung Medical Center/Division of Nephrology
  • Eulji General Hospital
  • Vilnius University Hospital Santariskiu Clinic, Public Institution, Centre of Nephrology
  • Spitalul Clinic Republican
  • Zaklad Diagnostyki Chorob Serca, II Katedra Kardiologii
  • Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
  • Specjalistyczny Szpital Zachodni im. Jana Pawla II w Grodzisku Mazowieckim
  • Krakowskie Centrum Medyczne NZOZ
  • Klinika Nefrologii, Hipertensjologii i Chorob Wewnetrznych Katedry Chorob Wewnetrznych UWM
  • Pracownia Echokardiografii, Oddzial Kardiologii
  • Centrum Medyczne Aesculap
  • Klinika Kardiologii
  • Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
  • Szpital Powiatowy w Wolominie
  • SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
  • Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea
  • Spitalul Clinic Dr. C. I. Parhon Iasi
  • Institutul Clinic Fundeni, Centrul de Medicina Interna-Nefrologie
  • SPITALUL CLINIC JUDETEAN DE URGENTA TIMISOARA ,Clinica de Nefrologie
  • Univerzitna nemocnica Bratislava
  • SUMMIT CLINICAL RESEARCH, s.r.o., Oddelenie internej mediciny a klinickej farmakologie
  • Hospital Universitari de Bellvitge
  • Hospital Clinic I Provincial de Barcelona
  • Sahlgrenska Universitetssjukhuset, Njurmedicin
  • Karolinska Universitetssjukhuset Huddinge
  • Karolinska Universitetssjukhuset Solna
  • Universitaetsspital Zuerich
  • Istanbul University, Istanbul Tip Fakultesi
  • Dokuz Eylul Universitesi Hastanesi Ic Hastaliklari Anabilim Dali
  • Morriston Hospital
  • BHF Glasgow Cardiovascular Research Centre, University of Glasgow
  • Renal and Urology Directorate, Leicester General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25
TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).

Secondary Outcome Measures

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination
eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV.
Time to First Occurrence or Worsening of Hypertension
The time to first occurrence or worsening of hypertension was observed (defined as the need for increased dose of or need for additional anti-hypertensive medication). The numbers presented correspond to the very first occurrence or worsening of hypertension in that treatment group.
Time to First Occurrence or Worsening of Back and/or Flank Pain
The time to first occurrence or worsening of back and/or flank pain was observed (defined as initial onset of polycystic kidney disease [PKD]-related chronic back and/or flank pain; initiation of pain medication treatment for PKD-related chronic back and/or flank pain; addition of a pain medicine for treatment of PKD-related chronic back and/or flank pain; increase in dose of pain medication for treatment of PKD-related chronic back and/or flank pain). The numbers presented correspond to the very first occurrence or worsening of back and/or flank pain in that treatment group.
Time to First Occurrence of Gross Hematuria
Gross hematuria is the presence of blood in the urine (defined as pink, red, or cola-colored urine due to the presence of red blood cells). The numbers presented correspond to the very first occurrence of gross hematuria in that treatment group.
Time to First Occurrence of Proteinuria
Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. The numbers presented correspond to the very first occurrence of proteinuria in that treatment group.
Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days
ESRD is when the kidneys permanently fail to work at a level needed for daily life. No participants developed ESRD during the treatment period, therefore the analysis of the onset of ESRD requiring ≥56 days of dialysis was not performed.
Number of Participants With High Blood Urea Nitrogen (BUN) Levels
A BUN test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high BUN level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.
Number of Participants With High Serum Creatinine (SCr) Levels
A SCr test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high SCr level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.
Maximum Observed Plasma Concentration (Cmax) of Bosutinib
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib
Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib
Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours.
Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib
Apparent Oral Clearance (CL/F) of Bosutinib
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F) of Bosutinib
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Terminal Elimination Half-Life (t1/2) of Bosutinib
t1/2 is the time measured for the plasma concentration to decrease by one half.
Observed Accumulation Ratio (Rac) of Bosutinib
Observed accumulation ratio (Rac) was calculated as AUC from time 0 to 24 hours (Day 15) divided by AUC from time 0 to 24 hours (Day 1).
Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25
The KDQoL-36 is a 36-item questionnaire on kidney disease-specific measure of patient-reported quality of life with 5 subscales: physical and mental functioning (items 1-12); burden of kidney disease subscale (items 13-16); symptoms and problems (items 17-28); effects of kidney disease on daily life subscale (items 29-36). The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better quality of life.

Full Information

First Posted
October 28, 2010
Last Updated
February 10, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01233869
Brief Title
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney, Autosomal Dominant
Keywords
Bosutinib, Autosomal Dominant Polycystic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Title
Cohort B
Arm Type
Experimental
Arm Title
Cohort C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Intervention Description
Once daily oral dose of 200 mg of bosutinib
Intervention Type
Drug
Intervention Name(s)
Bosutinib
Intervention Description
Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily oral dose of placebo
Primary Outcome Measure Information:
Title
Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25
Description
TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).
Time Frame
Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])
Secondary Outcome Measure Information:
Title
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination
Description
eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV.
Time Frame
Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination
Title
Time to First Occurrence or Worsening of Hypertension
Description
The time to first occurrence or worsening of hypertension was observed (defined as the need for increased dose of or need for additional anti-hypertensive medication). The numbers presented correspond to the very first occurrence or worsening of hypertension in that treatment group.
Time Frame
Baseline up to Month 25 (end of ITPV)
Title
Time to First Occurrence or Worsening of Back and/or Flank Pain
Description
The time to first occurrence or worsening of back and/or flank pain was observed (defined as initial onset of polycystic kidney disease [PKD]-related chronic back and/or flank pain; initiation of pain medication treatment for PKD-related chronic back and/or flank pain; addition of a pain medicine for treatment of PKD-related chronic back and/or flank pain; increase in dose of pain medication for treatment of PKD-related chronic back and/or flank pain). The numbers presented correspond to the very first occurrence or worsening of back and/or flank pain in that treatment group.
Time Frame
Baseline up to Month 25 (end of ITPV)
Title
Time to First Occurrence of Gross Hematuria
Description
Gross hematuria is the presence of blood in the urine (defined as pink, red, or cola-colored urine due to the presence of red blood cells). The numbers presented correspond to the very first occurrence of gross hematuria in that treatment group.
Time Frame
Baseline up to Month 25 (end of ITPV)
Title
Time to First Occurrence of Proteinuria
Description
Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. The numbers presented correspond to the very first occurrence of proteinuria in that treatment group.
Time Frame
Baseline up to Month 25 (end of ITPV)
Title
Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days
Description
ESRD is when the kidneys permanently fail to work at a level needed for daily life. No participants developed ESRD during the treatment period, therefore the analysis of the onset of ESRD requiring ≥56 days of dialysis was not performed.
Time Frame
Baseline up to Month 25 (end of ITPV)
Title
Number of Participants With High Blood Urea Nitrogen (BUN) Levels
Description
A BUN test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high BUN level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.
Time Frame
Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)
Title
Number of Participants With High Serum Creatinine (SCr) Levels
Description
A SCr test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high SCr level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.
Time Frame
Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)
Title
Maximum Observed Plasma Concentration (Cmax) of Bosutinib
Time Frame
Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib
Time Frame
Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
Title
Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib
Description
Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours.
Time Frame
Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
Title
Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib
Time Frame
Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
Title
Apparent Oral Clearance (CL/F) of Bosutinib
Description
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame
Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
Title
Apparent Volume of Distribution (Vz/F) of Bosutinib
Description
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time Frame
Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
Title
Terminal Elimination Half-Life (t1/2) of Bosutinib
Description
t1/2 is the time measured for the plasma concentration to decrease by one half.
Time Frame
Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
Title
Observed Accumulation Ratio (Rac) of Bosutinib
Description
Observed accumulation ratio (Rac) was calculated as AUC from time 0 to 24 hours (Day 15) divided by AUC from time 0 to 24 hours (Day 1).
Time Frame
Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
Title
Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25
Description
The KDQoL-36 is a 36-item questionnaire on kidney disease-specific measure of patient-reported quality of life with 5 subscales: physical and mental functioning (items 1-12); burden of kidney disease subscale (items 13-16); symptoms and problems (items 17-28); effects of kidney disease on daily life subscale (items 29-36). The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better quality of life.
Time Frame
Baseline and end of ITPV (Month 25)
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time Frame
Baseline up to 30 days after last study drug administration
Title
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
Description
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).
Time Frame
Baseline up to 30 days after last study drug administration
Title
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Description
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.
Time Frame
Baseline up to 30 days after last study drug administration
Title
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Description
ECGs were centrally evaluated. ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (≥)300 milliseconds (msec) or ≥25% increase when baseline is greater than (>)200 msec and ≥50% increase when baseline is less than or equal to (≤)200 msec; QRS interval ≥200 msec or ≥25%/50% increase from baseline; and QTcF ≥450 msec or ≥30 msec increase.
Time Frame
Baseline up to 30 days after last study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Kidney Institute, PLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Southwest Clinical Research Institute, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Southwest Kidney Institute, PLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Capital Nephrology Clinical Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Boise Kidney & Hypertension Institute, PLLC
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Boise Kidney & Hypertension Institute, PLLC
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Renal Associates of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University - HHC CTSI Clinical Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Doylestown Hospital MRI
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Nephrology/Hypertension Specialists
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Renal Associates, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Health System - Nephrology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Renal Remission and Hypertension Clinic
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Klinika gerontologicka a metabolicka
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Krajska nemocnice Liberec
City
Liberec 1
ZIP/Postal Code
460 63
Country
Czech Republic
Facility Name
Nemocnice Nove Mesto na Morave
City
Nove Mesto na Morave
ZIP/Postal Code
592 31
Country
Czech Republic
Facility Name
Fakultni poliklinika VFN
City
Praha 2
ZIP/Postal Code
128 00
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Pharmaceutical Research Associates CZ, s.r.o.
City
Praha 7
ZIP/Postal Code
170 00
Country
Czech Republic
Facility Name
PRA Magyarorszag Kft. Klinikai Farmakologiai Vizsgalohely
City
Budapest
ZIP/Postal Code
1077
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Szent Imre Korhaz BSZMI Klinikai Farmakologiai Reszlege
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont I.sz.Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Istituti Ospitalieri di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
A.O. Universitaria Ospedali Riuniti di Foggia
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Seoul National University Hospital, Department of Internal Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center/Division of Nephrology
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Eulji General Hospital
City
Seoul
ZIP/Postal Code
139-872
Country
Korea, Republic of
Facility Name
Vilnius University Hospital Santariskiu Clinic, Public Institution, Centre of Nephrology
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Spitalul Clinic Republican
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Zaklad Diagnostyki Chorob Serca, II Katedra Kardiologii
City
Gdansk
ZIP/Postal Code
80-210
Country
Poland
Facility Name
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Specjalistyczny Szpital Zachodni im. Jana Pawla II w Grodzisku Mazowieckim
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Krakowskie Centrum Medyczne NZOZ
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Klinika Nefrologii, Hipertensjologii i Chorob Wewnetrznych Katedry Chorob Wewnetrznych UWM
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Pracownia Echokardiografii, Oddzial Kardiologii
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Centrum Medyczne Aesculap
City
Radom
ZIP/Postal Code
26-600
Country
Poland
Facility Name
Klinika Kardiologii
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Szpital Powiatowy w Wolominie
City
Wolomin
ZIP/Postal Code
05-200
Country
Poland
Facility Name
SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea
City
Oradea
State/Province
jud. Bihor
ZIP/Postal Code
410469
Country
Romania
Facility Name
Spitalul Clinic Dr. C. I. Parhon Iasi
City
Iasi
State/Province
jud. Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Institutul Clinic Fundeni, Centrul de Medicina Interna-Nefrologie
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
SPITALUL CLINIC JUDETEAN DE URGENTA TIMISOARA ,Clinica de Nefrologie
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Univerzitna nemocnica Bratislava
City
Limbova 5
State/Province
Bratislava
ZIP/Postal Code
83305
Country
Slovakia
Facility Name
SUMMIT CLINICAL RESEARCH, s.r.o., Oddelenie internej mediciny a klinickej farmakologie
City
Bratislava
ZIP/Postal Code
831 01
Country
Slovakia
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset, Njurmedicin
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Universitaetsspital Zuerich
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Istanbul University, Istanbul Tip Fakultesi
City
Istanbul
State/Province
Capa
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Hastanesi Ic Hastaliklari Anabilim Dali
City
Izmir
State/Province
Inciralti/ Narlidere
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Morriston Hospital
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
BHF Glasgow Cardiovascular Research Centre, University of Glasgow
City
Glasgow
ZIP/Postal Code
G12 8TA
Country
United Kingdom
Facility Name
Renal and Urology Directorate, Leicester General Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28838955
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871019&StudyName=Bosutinib%20For%20Autosomal%20Dominant%20Polycystic%20Kidney%20Disease
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Bosutinib For Autosomal Dominant Polycystic Kidney Disease

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