Bosutinib For Autosomal Dominant Polycystic Kidney Disease

NCT01233869

Last updated date
Study Location
Southwest Kidney Institute, PLC
Phoenix, Arizona, 85004, United States
Contact
1-800-718-1021

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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 < 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.

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Autosomal Dominant Polycystic KidneyBosutinib For Autosomal Dominant Polycystic Kidney Disease
NCT01233869
  1. Phoenix, Arizona
  2. Tempe, Arizona
  3. Tempe, Arizona
  4. Sacramento, California
  5. Caldwell, Idaho
  6. Meridian, Idaho
  7. Baton Rouge, Louisiana
  8. Boston, Massachusetts
  9. St. Louis, Missouri
  10. St. Louis, Missouri
  11. New York, New York
  12. Doylestown, Pennsylvania
  13. Doylestown, Pennsylvania
  14. Doylestown, Pennsylvania
  15. San Antonio, Texas
  16. San Antonio, Texas
  17. Charlottesville, Virginia
  18. Charlottesville, Virginia
  19. Seattle, Washington
  20. Silverdale, Washington
  21. Clayton, Victoria
  22. Toronto, Ontario
  23. Montreal, Quebec
  24. Hradec Kralove,
  25. Liberec 1,
  26. Nove Mesto na Morave,
  27. Praha 2,
  28. Praha 2,
  29. Praha 7,
  30. Budapest,
  31. Budapest,
  32. Szeged,
  33. Cremona,
  34. Foggia,
  35. Seoul,
  36. Seoul,
  37. Seoul,
  38. Vilnius,
  39. Chisinau,
  40. Gdansk,
  41. Gdansk,
  42. Grodzisk Mazowiecki,
  43. Krakow,
  44. Olsztyn,
  45. Olsztyn,
  46. Radom,
  47. Szczecin,
  48. Szczecin,
  49. Wolomin,
  50. Wroclaw,
  51. Oradea, jud. Bihor
  52. Iasi, jud. Iasi
  53. Bucuresti,
  54. Timisoara,
  55. Limbova 5, Bratislava
  56. Bratislava,
  57. Hospitalet de Llobregat, Barcelona
  58. Barcelona,
  59. Goteborg,
  60. Stockholm,
  61. Stockholm,
  62. Zuerich,
  63. Istanbul, Capa
  64. Izmir, Inciralti/ Narlidere
  65. Swansea, Wales
  66. Glasgow,
  67. Leicester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary 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.
Detailed Description Not 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 Date July 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 Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2016

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