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Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Last updated on October 10, 2019

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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Descriptive Information
Brief Title  ICMJE Bosutinib For Autosomal Dominant Polycystic Kidney Disease
Official Title  ICMJE 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)
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Kidney, Autosomal Dominant
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort A
    Intervention: Drug: Bosutinib
  • Experimental: Cohort B
    Intervention: Drug: Bosutinib
  • Placebo Comparator: Cohort C
    Intervention: Drug: Placebo
Publications *Tesar V, Ciechanowski K, Pei Y, Barash I, Shannon M, Li R, Williams JH, Levisetti M, Arkin S, Serra A. Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2017 Nov;28(11):3404-3413. doi: 10.1681/ASN.2016111232. Epub 2017 Aug 24.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2014)
172
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2010)
275
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion DateJuly 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Czech Republic,   Hungary,   Italy,   Korea, Republic of,   Lithuania,   Moldova, Republic of,   Poland,   Romania,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01233869
Other Study ID Numbers  ICMJE B1871019
3160A7-2211 ( Other Identifier: Alias Study Number )
2010-023017-65 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2016

ICMJE     Data element required by the

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

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