At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 172 enrolled
Drug / intervention
Bosutinib +2 moredrug
Likely dose
Bosutinib 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Bosutinib and Placebo for Polycystic Kidney, Autosomal Dominant. Completed, enrolled 172 participants across 67 sites in 17 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Kidney, Autosomal Dominant
CountriesAustralia, Canada, Czechia, Hungary, Italy, Lithuania, Moldova, Poland, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartDec 2010
Primary CompletionJul 2014
Study CompletionAug 2014
TodayJul 2026
First PostedNov 3, 2010
Enrollment StartDec 1, 2010
Primary CompletionJul 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.7 years ago
Interventions
Bosutinibdrug
Once daily oral dose of 200 mg of bosutinib
Bosutinibdrug
Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
Placebodrug
Once daily oral dose of placebo