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Bosutinib For Autosomal Dominant Polycystic Kidney Disease

NCT01233869 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2016-03-11

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Hungary
  • Italy
  • Lithuania
  • Moldova
  • Poland
  • Romania
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01233869 on ClinicalTrials.gov