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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01233869
First received: October 28, 2010
Last updated: September 9, 2014
Last verified: September 2014
  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.


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:


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 ]

Enrollment: 172
Study Start Date: December 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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
Experimental: Cohort B Drug: Bosutinib
Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233869

  Show 69 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: September 9, 2014
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, Autosomal Dominant
Polycystic Kidney Diseases
Multicystic Dysplastic Kidney
Urologic Diseases
Kidney Diseases, Cystic
Urogenital Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 30, 2014