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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01233869
Registration number
NCT01233869
Ethics application status
Date submitted
28/10/2010
Date registered
3/11/2010
Date last updated
11/03/2016
Titles & IDs
Public title
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
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Scientific 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)
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Secondary ID [1]
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3160A7-2211
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Secondary ID [2]
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B1871019
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polycystic Kidney, Autosomal Dominant
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bosutinib
Treatment: Drugs - Bosutinib
Treatment: Drugs - Placebo
Experimental: Cohort A -
Experimental: Cohort B -
Placebo comparator: Cohort C -
Treatment: Drugs: Bosutinib
Once daily oral dose of 200 mg of bosutinib
Treatment: Drugs: Bosutinib
Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
Treatment: Drugs: Placebo
Once daily oral dose of placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25
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Assessment method [1]
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TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).
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Timepoint [1]
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Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])
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Secondary outcome [1]
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Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination
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Secondary outcome [2]
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Time to First Occurrence or Worsening of Hypertension
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to Month 25 (end of ITPV)
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Secondary outcome [3]
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Time to First Occurrence or Worsening of Back and/or Flank Pain
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline up to Month 25 (end of ITPV)
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Secondary outcome [4]
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Time to First Occurrence of Gross Hematuria
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline up to Month 25 (end of ITPV)
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Secondary outcome [5]
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Time to First Occurrence of Proteinuria
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline up to Month 25 (end of ITPV)
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Secondary outcome [6]
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Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline up to Month 25 (end of ITPV)
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Secondary outcome [7]
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Number of Participants With High Blood Urea Nitrogen (BUN) Levels
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Assessment method [7]
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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.
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Timepoint [7]
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Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)
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Secondary outcome [8]
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Number of Participants With High Serum Creatinine (SCr) Levels
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Assessment method [8]
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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.
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Timepoint [8]
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Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)
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Secondary outcome [9]
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Maximum Observed Plasma Concentration (Cmax) of Bosutinib
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Assessment method [9]
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Timepoint [9]
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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)
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Secondary outcome [10]
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib
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Assessment method [10]
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Timepoint [10]
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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)
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Secondary outcome [11]
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Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib
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Assessment method [11]
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Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours.
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Timepoint [11]
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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)
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Secondary outcome [12]
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Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib
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Assessment method [12]
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Timepoint [12]
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Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
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Secondary outcome [13]
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Apparent Oral Clearance (CL/F) of Bosutinib
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Assessment method [13]
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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.
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Timepoint [13]
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Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
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Secondary outcome [14]
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Apparent Volume of Distribution (Vz/F) of Bosutinib
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Assessment method [14]
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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.
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Timepoint [14]
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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)
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Secondary outcome [15]
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Terminal Elimination Half-Life (t1/2) of Bosutinib
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Assessment method [15]
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t1/2 is the time measured for the plasma concentration to decrease by one half.
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Timepoint [15]
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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)
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Secondary outcome [16]
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Observed Accumulation Ratio (Rac) of Bosutinib
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Assessment method [16]
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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).
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Timepoint [16]
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Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)
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Secondary outcome [17]
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Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline and end of ITPV (Month 25)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
50
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2014
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Sample size
Target
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Accrual to date
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Final
172
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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California
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United States of America
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Idaho
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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New York
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Country [8]
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United States of America
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State/province [8]
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Pennsylvania
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United States of America
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State/province [9]
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Texas
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Country [10]
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United States of America
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State/province [10]
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Virginia
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United States of America
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Washington
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Canada
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Ontario
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Canada
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Quebec
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Country [14]
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Czech Republic
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Hradec Kralove
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Czech Republic
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Liberec 1
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Country [16]
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Czech Republic
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Nove Mesto na Morave
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Country [17]
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Czech Republic
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Praha 2
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Country [18]
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Czech Republic
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Praha 7
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Hungary
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Budapest
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Hungary
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Szeged
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Italy
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Cremona
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Italy
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Foggia
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Korea, Republic of
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Seoul
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Lithuania
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Vilnius
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Country [25]
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Moldova, Republic of
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State/province [25]
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Chisinau
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Poland
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Gdansk
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Poland
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Grodzisk Mazowiecki
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Poland
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Krakow
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Poland
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Olsztyn
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Poland
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Radom
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Poland
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Szczecin
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Poland
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Wolomin
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Country [33]
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Poland
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State/province [33]
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Wroclaw
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Romania
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jud. Bihor
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Romania
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State/province [35]
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jud. Iasi
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Romania
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State/province [36]
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Bucuresti
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Romania
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Timisoara
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Slovakia
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Bratislava
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Spain
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Barcelona
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Sweden
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Goteborg
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Sweden
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Stockholm
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Switzerland
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Zuerich
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Turkey
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Capa
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Turkey
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Inciralti/ Narlidere
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United Kingdom
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Wales
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United Kingdom
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State/province [46]
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Glasgow
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Country [47]
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United Kingdom
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State/province [47]
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Leicester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01233869
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01233869
Download to PDF