A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/22/2017
Start Date:March 5, 2013
End Date:January 27, 2017

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A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

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).

Subjects will be followed for 6 months. Upon completion of the first 6 months of the study,
subjects may participate in the Long Term Extension period of the study. Subjects will
remain on their original treatment arm up to three years post-transplant (and / or Sponsor
discontinues development or the subject no longer wishes to participate in the study).

Inclusion Criteria:

- Subject is a recipient of a de novo kidney from a living or deceased donor

Exclusion Criteria:

- Subject has induction therapy, other than study-assigned basiliximab, planned as part
of initial immunosuppressive regimen

- Subject has previously received or is receiving an organ transplant other than a
kidney

- Subject will receive a solitary kidney from a deceased donor < 5 years of age

- Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30
hours

- Subject will receive a kidney that meets both Extended Criteria Donor (ECD) and
Donation after Cardiac Death (DCD) criteria. Note: a kidney that meets either ECD or
DCD criteria is eligible for inclusion

- Subject will receive an ABO incompatible donor kidney

- Subject has a current calculated panel reactive antibody (cPRA) level >50%
We found this trial at
36
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 30322
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Atlanta, GA
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Augusta, Georgia 30909
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Augusta, GA
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Aurora, Colorado 80045
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Baltimore, Maryland 21205
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Birmingham, Alabama 35294
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Birmingham, AL
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Buffalo, New York 14263
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Buffalo, NY
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Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Charleston, South Carolina 29424
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Charleston, SC
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Charlotte, North Carolina 28209
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Charlotte, NC
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Charlottesville, Virginia 22903
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Chicago, Illinois 60612
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Chicago, IL
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Cincinnati, Ohio 45242
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Cleveland, Ohio 44106
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Dallas, Texas 75246
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Durham, North Carolina 27710
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Durham, NC
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Fort Worth, Texas 76104
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Fort Worth, TX
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Greenville, North Carolina 27858
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Harrisburg, Pennsylvania 17011
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Harrisburg, PA
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Houston, Texas 77030
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Houston, TX
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Lexington, Kentucky 40536
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Lexington, KY
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Livingston, New Jersey 07039
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Livingston, NJ
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Los Angeles, California 90033
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Los Angeles, CA
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Madison, Wisconsin 53792
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Madison, WI
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Memphis, Tennessee 38105
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Nashville, Tennessee 37232
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New Orleans, Louisiana 70112
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New York, New York 10032
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Palo Alto, California 94304
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Phoenix, Arizona 85014
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Pittsburgh, Pennsylvania 15213
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84143
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San Diego, California 92123
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San Francisco, California 94143
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The Bronx, New York 10467
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The Bronx, NY
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