Study summary

This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first year post-transplant.

Additional Study Details

Phase
4
Product
  • Tacrolimus
  • Tacrolimus immediate release
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    599
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for To compare the effects of immediate-release tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) formation and the development of Immune Activation (IA) in de novo kidney transplant recipients? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

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      Locations

      Contact Us
      Contact Us
      Completed
      Site US10023
      Madison, WI, United States, 53792
      Completed
      Site US10037
      New York, NY, United States, 10032
      Completed
      Site US10002
      Charleston, SC, United States, 29425
      Completed
      Site US10020
      Chicago, IL, United States, 60605
      Completed
      Site US10021
      Syracuse, NY, United States, 13210
      Completed
      Site US10001
      Baltimore, MD, United States, 21201
      Completed
      Site US10005
      Sacramento, CA, United States, 95817
      Completed
      Site US10014
      Washington, DC, United States, 20007
      Completed
      Site US10029
      Minneapolis, MN, United States, 55455
      Completed
      Site US10027
      Rochester, MN, United States, 55905
      Completed
      Site US10003
      New Haven, CT, United States, 06510
      Completed
      Site US10028
      New York, NY, United States, 10467
      Completed
      Site US10031
      Los Angeles, CA, United States, 90033
      Completed
      Site US10016
      San Francisco, CA, United States, 94115
      Completed
      Site US10013
      Ann Arbor, MI, United States, 48109
      Completed
      Site US10022
      New York City, NY, United States, 10065
      Completed
      Site US10036
      Houston, TX, United States, 77030
      Completed
      Site US10019
      Livingston, NJ, United States, 07039
      Completed
      Site US10018
      Salt Lake City, UT, United States, 84112
      Completed
      Site US10012
      Charlottesville, VA, United States, 22903
      Completed
      Site US10008
      Falls Church, VA, United States, 22042
      Completed
      Site US10010
      Chicago, IL, United States, 60611
      Completed
      Site US10007
      Boston, MA, United States, 02114
      Completed
      Site US10026
      Portland, OR, United States, 97210
      Completed
      Site US10032
      Detroit, MI, United States, 48202
      Completed
      Site US10004
      Buffalo, NY, United States, 14215
      Completed
      Site US10024
      Aurora, CO, United States, 80045
      Completed
      Site US10006
      Birmingham, AL, United States, 35294
      Withdrawn
      Site US10035
      Los Angeles, CA, United States, 90048
      Completed
      Site US10025
      Scottsdale, AZ, United States, 85259
      Completed
      Site US10030
      Jacksonville, FL, United States, 32224

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