Subject will be excluded from participation if any of the following apply:
1. Subject has Induction therapy, other than study-assigned basiliximab, planned as part of
initial immunosuppressive regimen.
2. Subject has previously received or is receiving an organ transplant other than a kidney.
3. Subject will receive a solitary kidney from a deceased donor < 5 years of age.
4. Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours.
5. 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.
6. Subject will receive an ABO incompatible donor kidney.
7. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
8. Subject's most recent cPRA level >50%.
9. Subject has a positive T or B cell crossmatch by NIH antiglobulin lymphocytotoxicity
method, if performed.
10. Subject has a positive T or B cell flow cytometry crossmatch AND donor specific anti-HLA
antibody (DSA) detected by flow cytometry/Luminex® based, specific anti-HLA antibody
testing, if performed.
11. Subject has a current malignancy or a history of malignancy (within the past 5 years), except
non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully,
or a renal cell carcinoma that has been treated successfully more than 2 years prior to
12. Subject has significant liver disease, defined as having during the past 28 days consistently
elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the
normal range of the investigational site.
13. Subject is known to have a positive test for latent tuberculosis (TB) and has not previously received adequate anti-microbial or would require TB prophylaxis after transplant.
14. Subject has an uncontrolled concomitant infection or any other unstable medical condition
that could interfere with the study objectives.
15. Subject is concurrently participating in another drug study or has received an investigational
drug up to 30 days or 5 half-lives (depending on medication) prior to transplant.
16. Subject is currently receiving or has received up to 8 weeks prior to transplant an
immunologic biologic compound (i.e. TNF inhibitors, (i.e., etanercept, adalimumab), IVIG).
17. Subject has previously received ASKP1240 or participated in a clinical study with
18. Subject has a known hypersensitivity to tacrolimus, basiliximab, mycophenolate mofetil,
corticosteroids, or any of their components.
19. Subject has any form of substance abuse, psychiatric disorder, or a condition that in the
opinion of the Investigator could invalidate communication with the Investigator.
20. Subject has a clinically significant abnormal ECG at Screening.
21. Subject is unlikely to comply with the visits scheduled in the protocol, in the opinion of the
Waivers to the exclusion criteria will NOT be allowed.