Study summary

The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).

Additional Study Details

Phase
2
Product
  • ASKP1240
  • Tacrolimus
  • Mycophenolate Mofetil (MMF)
  • Basiliximab
  • Methylprednisone
  • Prednisone
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    149
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A Study to Assess the Efficacy and Safety of ASKP1240 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

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      Completed
      Site US10015
      Lexington, KY, United States, 40536
      Completed
      Site US10026
      Greenville, NC, United States, 27834
      Completed
      Site US10019
      Bronx, NY, United States, 10467
      Completed
      Site US10003
      San Francisco, CA, United States, 94143
      Completed
      Site US10001
      Dallas, TX, United States, 75246
      Completed
      Site US10017
      Ann Arbor, MI, United States, 48109
      Completed
      Site US10044
      Houston, TX, United States, 77030
      Completed
      Site US10016
      Durham, NC, United States, 27710
      Completed
      Site US10035
      Nashville, TN, United States, 37232-4750
      Completed
      Site US10014
      Baltimore, MD, United States, 21201
      Completed
      Site US10018
      Chicago, IL, United States, 60612
      Completed
      Site US10007
      Atlanta, GA, United States, 30322
      Completed
      Site US10010
      Chicago, IL, United States, 60612
      Completed
      Site US10031
      Buffalo, NY, United States, 14215
      Completed
      Site US10027
      Harrisburg, PA, United States, 17011
      Completed
      Site US10009
      Cincinnati, OH, United States, 45267
      Completed
      Site US10033
      Salt Lake City, UT, United States, 84132
      Completed
      Site US10020
      Charlottesville, VA, United States, 22908
      Completed
      Site US10037
      Chicago, IL, United States, 60637
      Completed
      Site US10013
      Aurora, CO, United States, 80045
      Completed
      Site US10040
      Cleveland, OH, United States, 44106
      Completed
      Site US10042
      Charlotte, NC, United States, 28203
      Completed
      Site US10032
      Cleveland, OH, United States, 44195
      Completed
      Site US10023
      New York, NY, United States, 10065
      Completed
      Site US10008
      Los Angeles, CA, United States, 90057
      Completed
      Site US10012
      Charleston, SC, United States, 29425
      Completed
      Site US10025
      St. Louis, MO, United States, 63110
      Completed
      Site US10045
      New Orleans, LA, United States, 70112
      Completed
      Site US10004
      San Francisco, CA, United States, 94115
      Completed
      Site US10021
      Palo Alto, CA, United States, 94304
      Completed
      Site US10030
      San Diego, CA, United States, 92123
      Completed
      Site US10005
      Madison, WI, United States, 53792
      Completed
      Site US10036
      Chapel Hill, NC, United States, 27599
      Completed
      Site US10024
      Phoenix, AZ, United States, 85054
      Completed
      Site US10034
      New York, NY, United States, 10029
      Completed
      Site US10029
      Houston, TX, United States, 77030
      Completed
      Site US10041
      Augusta, GA, United States, 30912
      Completed
      Site US10002
      Fort Worth, TX, United States, 76104
      Completed
      Site US10006
      Birmingham, AL, United States, 35233
      Completed
      Site US10038
      Pittsburgh, PA, United States, 15213
      Completed
      Site US10022
      Livingston, NJ, United States, 07039
      Completed
      Site US10028
      Memphis, TN, United States, 38104

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