Trial record 1 of 1 for:    Bosutinib for ADPKD
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Bosutinib For Autosomal Dominant Polycystic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01233869
First received: October 28, 2010
Last updated: October 27, 2014
Last verified: October 2014

October 28, 2010
October 27, 2014
December 2010
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01233869 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Demonstrate that reduction in the rate of kidney enlargement is predictive of a reduction in rate of decline of eGFR by evaluating total kidney volume and rate of decline of eGFR after 24 months and up to 72 months of treatment respectively. [ Time Frame: 72 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Kidney, Autosomal Dominant
  • 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
  • Experimental: Cohort A
    Intervention: Drug: Bosutinib
  • Experimental: Cohort B
    Intervention: Drug: Bosutinib
  • Placebo Comparator: Cohort C
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
September 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   United Kingdom,   United States,   Poland,   Turkey,   Korea, Republic of,   Czech Republic,   Hungary,   Canada,   Spain,   Romania,   Sweden,   Australia,   Moldova, Republic of,   Slovakia,   Switzerland,   Lithuania
 
NCT01233869
B1871019, 3160A7-2211, 2010-023017-65
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP