Bosutinib For Autosomal Dominant Polycystic Kidney Disease

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

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.