Status:
COMPLETED
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
Lead Sponsor:
Pfizer
Conditions:
Polycystic Kidney, Autosomal Dominant
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 kid...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT01233869
Start Date
December 1 2010
End Date
August 1 2014
Last Update
March 11 2016
Active Locations (67)
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1
Southwest Kidney Institute, PLC
Phoenix, Arizona, United States, 85004
2
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States, 85284
3
Southwest Kidney Institute, PLC
Tempe, Arizona, United States, 85284
4
Capital Nephrology Clinical Research
Sacramento, California, United States, 95825