Bosutinib For Autosomal Dominant Polycystic Kidney Disease



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:December 2010
End Date:August 2014

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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)

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.


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.
We found this trial at
21
sites
Doylestown, Pennsylvania 18901
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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St. Louis, MO
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Baton Rouge, Louisiana 70808
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Baton Rouge, LA
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Caldwell, ID
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Charlottesville, Virginia 22908
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Charlottesville, VA
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, VA
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Clayton, Victoria 3168
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Clayton,
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Doylestown, Pennsylvania 18901
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Doylestown, PA
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Doylestown, Pennsylvania 18901
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Meridian, ID
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New York, NY
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Phoenix, Arizona 85004
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Phoenix, AZ
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Sacramento, California 95825
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Sacramento, CA
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San Antonio, TX
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San Antonio, Texas
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Seattle, Washington 98122
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Seattle, WA
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Silverdale, Washington 98383
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Silverdale, WA
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St. Louis, Missouri 63108
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Tempe, Arizona 85284
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Tempe, AZ
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Tempe, AZ
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