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
347
mi
from
Dallas, TX
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Ann Arbor, Michigan 48109
810
mi
from
Ann Arbor, MI
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Atlanta, Georgia 30322
803
mi
from
Atlanta, GA
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Augusta, Georgia 30909
931
mi
from
Augusta, GA
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Aurora, Colorado 80045
401
mi
from
Aurora, CO
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Baltimore, Maryland 21205
1148
mi
from
Baltimore, MD
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Birmingham, Alabama 35294
683
mi
from
Birmingham, AL
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Buffalo, New York 14263
1056
mi
from
Buffalo, NY
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Chapel Hill, North Carolina 27514
843
mi
from
Chapel Hill, NC
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Charleston, South Carolina 29424
1063
mi
from
Charleston, SC
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Charlotte, North Carolina 28209
957
mi
from
Charlotte, NC
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Charlottesville, Virginia 22903
1053
mi
from
Charlottesville, VA
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Chicago, Illinois 60612
609
mi
from
Chicago, IL
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Cincinnati, Ohio 45242
728
mi
from
Cincinnati, OH
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Cleveland, Ohio 44106
894
mi
from
Cleveland, OH
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Durham, North Carolina 27710
1048
mi
from
Durham, NC
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Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
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Greenville, North Carolina 27858
1140
mi
from
Greenville, NC
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Harrisburg, Pennsylvania 17011
1134
mi
from
Harrisburg, PA
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Houston, Texas 77030
572
mi
from
Houston, TX
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Lexington, Kentucky 40536
727
mi
from
Lexington, KY
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Livingston, New Jersey 07039
1270
mi
from
Livingston, NJ
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Los Angeles, California 90033
1168
mi
from
Los Angeles, CA
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Madison, Wisconsin 53792
575
mi
from
Madison, WI
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Memphis, Tennessee 38105
468
mi
from
Memphis, TN
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Nashville, Tennessee 37232
618
mi
from
Nashville, TN
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New Orleans, Louisiana 70112
697
mi
from
New Orleans, LA
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New York, New York 10032
1225
mi
from
New York, NY
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Palo Alto, California 94304
1327
mi
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Palo Alto, CA
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Phoenix, Arizona 85014
850
mi
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
971
mi
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Pittsburgh, PA
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Saint Louis, Missouri 63110
418
mi
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Saint Louis, MO
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Salt Lake City, Utah 84143
779
mi
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Salt Lake City, UT
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San Diego, California 92123
1099
mi
from
San Diego, CA
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San Francisco, California 94143
1181
mi
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San Francisco, CA
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The Bronx, New York 10467
?
mi
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The Bronx, NY
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