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

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 caregiver
  • A healthcare provider
  • A parent
  • A patient
  • 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 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

    Frequently Asked Questions

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    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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