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 |
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.
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
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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