NCT01233869

Bosutinib For Autosomal Dominant Polycystic Kidney Disease

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Kidney, Autosomal Dominant

Interventions

Type	Name	Description
DRUG	Bosutinib	Once daily oral dose of 200 mg of bosutinib
DRUG	Bosutinib	Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
DRUG	Placebo	Once daily oral dose of placebo

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2010-11-03
• Last updated: 2016-03-11
• Results posted: 2015-10-28

Locations

67 sites across 17 countries: United States, Australia, Canada, Czechia, Hungary, Italy, Lithuania, Moldova, Poland, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom