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Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Southwest Kidney Institute, PLC
Phoenix, Arizona, 85004 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Autosomal Dominant Polycystic Kidney
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- eGFR

- 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.

NCT01233869
Pfizer
Completed
Bosutinib For Autosomal Dominant Polycystic Kidney Disease

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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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
August 2014
July 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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czech Republic,   Hungary,   Italy,   Korea, Republic of,   Lithuania,   Moldova, Republic of,   Poland,   Romania,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   United States
 
 
NCT01233869
B1871019
3160A7-2211 ( Other Identifier: Alias Study Number )
2010-023017-65 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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