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
Chicago, Illinois 60612
1728
mi
from 91732
Chicago, IL
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Ann Arbor, Michigan 48109
1934
mi
from 91732
Ann Arbor, MI
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Atlanta, Georgia 30322
1922
mi
from 91732
Atlanta, GA
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Augusta, Georgia 30909
2053
mi
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Augusta, GA
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Aurora, Colorado 80045
825
mi
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Aurora, CO
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Baltimore, Maryland 21205
2301
mi
from 91732
Baltimore, MD
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Birmingham, Alabama 35294
1785
mi
from 91732
Birmingham, AL
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Buffalo, New York 14263
2180
mi
from 91732
Buffalo, NY
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Chapel Hill, North Carolina 27514
1991
mi
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Chapel Hill, NC
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Charleston, South Carolina 29424
2184
mi
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Charleston, SC
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Charlotte, North Carolina 28209
2101
mi
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Charlotte, NC
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Charlottesville, Virginia 22903
2208
mi
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Charlottesville, VA
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Cincinnati, Ohio 45242
1882
mi
from 91732
Cincinnati, OH
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Cleveland, Ohio 44106
2032
mi
from 91732
Cleveland, OH
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Dallas, Texas 75246
1223
mi
from 91732
Dallas, TX
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Durham, North Carolina 27710
2199
mi
from 91732
Durham, NC
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Fort Worth, Texas 76104
1195
mi
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Fort Worth, TX
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Greenville, North Carolina 27858
2290
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Greenville, NC
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Harrisburg, Pennsylvania 17011
2283
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Harrisburg, PA
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Houston, Texas 77030
1357
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Houston, TX
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Lexington, Kentucky 40536
1882
mi
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Lexington, KY
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Livingston, New Jersey 07039
2416
mi
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Livingston, NJ
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Los Angeles, California 90033
13
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Los Angeles, CA
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Madison, Wisconsin 53792
1655
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Madison, WI
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Memphis, Tennessee 38105
1587
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Memphis, TN
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Nashville, Tennessee 37232
1762
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Nashville, TN
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New Orleans, Louisiana 70112
1655
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New Orleans, LA
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New York, New York 10032
2351
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New York, NY
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Palo Alto, California 94304
328
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Palo Alto, CA
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Phoenix, Arizona 85014
344
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
2119
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Pittsburgh, PA
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Saint Louis, Missouri 63110
1573
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Saint Louis, MO
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Salt Lake City, Utah 84143
572
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Salt Lake City, UT
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San Diego, California 92123
124
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San Diego, CA
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San Francisco, California 94143
41
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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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