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
sites
Dallas, Texas 75246
911
mi
from 43215
Dallas, TX
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Ann Arbor, Michigan 48109
165
mi
from 43215
Ann Arbor, MI
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Atlanta, Georgia 30322
432
mi
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Atlanta, GA
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Augusta, Georgia 30909
452
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Augusta, GA
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Aurora, Colorado 80045
1154
mi
from 43215
Aurora, CO
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Baltimore, Maryland 21205
344
mi
from 43215
Baltimore, MD
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Birmingham, Alabama 35294
492
mi
from 43215
Birmingham, AL
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Buffalo, New York 14263
294
mi
from 43215
Buffalo, NY
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Chapel Hill, North Carolina 27514
278
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Chapel Hill, NC
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Charleston, South Carolina 29424
524
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Charleston, SC
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Charlotte, North Carolina 28209
348
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Charlotte, NC
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Charlottesville, Virginia 22903
278
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Charlottesville, VA
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Chicago, Illinois 60612
274
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Chicago, IL
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Cincinnati, Ohio 45242
94
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Cincinnati, OH
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Cleveland, Ohio 44106
126
mi
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Cleveland, OH
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Durham, North Carolina 27710
352
mi
from 43215
Durham, NC
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Fort Worth, Texas 76104
938
mi
from 43215
Fort Worth, TX
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Greenville, North Carolina 27858
430
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Greenville, NC
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Harrisburg, Pennsylvania 17011
324
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Harrisburg, PA
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Houston, Texas 77030
995
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Houston, TX
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Lexington, Kentucky 40536
157
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Lexington, KY
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Livingston, New Jersey 07039
461
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Livingston, NJ
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Los Angeles, California 90033
1972
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Los Angeles, CA
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Madison, Wisconsin 53792
393
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Madison, WI
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Memphis, Tennessee 38105
507
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Memphis, TN
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Nashville, Tennessee 37232
334
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Nashville, TN
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New Orleans, Louisiana 70112
797
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New Orleans, LA
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New York, New York 10032
442
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New York, NY
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Palo Alto, California 94304
2099
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Palo Alto, CA
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Phoenix, Arizona 85014
1660
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
163
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Pittsburgh, PA
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Saint Louis, Missouri 63110
394
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Saint Louis, MO
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Salt Lake City, Utah 84143
1513
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Salt Lake City, UT
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San Diego, California 92123
1908
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San Diego, CA
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San Francisco, California 94143
1982
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San Francisco, CA
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The Bronx, New York 10467
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The Bronx, NY
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