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Bosutinib For Autosomal Dominant Polycystic Kidney Disease

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01233869
First received: October 28, 2010
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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 and to identify a safe and efficacious dose of bosutinib to be utilized for future studies.


Condition Intervention Phase
Polycystic Kidney, Autosomal Dominant
 Drug: Bosutinib
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Drug Information available for: Bosutinib
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Annualized rate (%) of kidney enlargement relative to placebo [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety endpoints to include incidence of AEs and SAEs, changes in laboratory test results, including ECGs, and changes in vital signs [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of treatment with bosutinib on renal function evaluations including blood urea nitrogen and serum and urine creatinine. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to first occurence (or worsening) of clinical measures of disease activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Serum concentrations of bosutinib will be measured, PK parameters (Cmax, Tmax, AUCt, Cl/F, Vz/F, t1/2 and R) will be calculated [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Subject-reported, disease specific quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 172
Study Start Date: December 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A Drug: Bosutinib
Once daily oral dose of 200 mg of bosutinib plus matching placebo
Experimental: Cohort B Drug: Bosutinib
Once daily oral dose of 400 mg of bosutinib
Placebo Comparator: Cohort C Drug: Placebo
Once daily oral dose of placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233869

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 67 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01233869     History of Changes
Other Study ID Numbers: B1871019, 3160A7-2211
Study First Received: October 28, 2010
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bosutinib
Autosomal Dominant Polycystic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on May 21, 2013