|Principal Investigator: FuadShihab|
|Keywords: Immunosuppression , Post renal transplant , CNI avoidance , Solid organ transplant||Department: Nephrology|
|IRB Number: 00061371||Co Investigator: LonnieSmith|
|Specialty: Transplant Surgery, Nephrology and Hypertension|
|Sub Specialties: Kidney Transplant, Kidney Transplant|
The primary objectives of this study are:
- to compare the efficacy of basiliximab induction, ASKP1240, tacrolimus, and steroids to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + mycophenolate mofetil [MMF] + steroids).
- to compare the efficacy of basiliximab induction, ASKP1240, MMF, and steroids to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).
The secondary objective of this study is:
to compare the safety of the experimental arms to the standard of care arm
Subject is eligible for the study if all of the following apply:
1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written
Informed Consent and privacy language as per national regulations (e.g., HIPAA
Authorization for U.S. sites) must be obtained from the subject or legally authorized
representative prior to any study-related procedures (including withdrawal of prohibited
medication, if applicable).
2. Male or female subject must be ≥ 18 years of age.
3. Subject is a recipient of a de novo kidney from a living or deceased donor.
4. Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant
5. Female subject must be either:
post-menopausal (defined as at least 1 year without any menses) prior to Screening,
premenarchal prior to Screening, or
documented surgically sterile or status post hysterectomy (at least 1 month prior to
if of childbearing potential, must have a negative serum pregnancy test at Screening
and if sexually active must be using highly effective contraception1. Sexually active
subjects will be required to use highly effective contraception consisting of two
forms of birth control (one of which must be a barrier method) starting at Screening
and throughout the study period and for 90 days after final study drug
6. Female subject must not be lactating and must not be breastfeeding at Screening or during
the study period and for 90 days after final study drug administration.
7. Female subject must not donate ova starting at Screening and throughout the study period
and for 90 days after final study drug administration.
8. Male subject and female spouse/partners who are of childbearing potential must be using
highly effective contraception1 consisting of two forms of birth control (one of which must
be a barrier method) starting at Screening and continue throughout the study period and for
90 days after the last dose of study drug.
9. Male subject must not donate sperm starting at Screening and throughout the study period
and for at least 90 days after the last dose of study drug.
10. Subject must be willing and able to comply with the study requirements including
prohibited concomitant medication restrictions.
11. Subject agrees not to participate in another interventional study while on treatment.
Wiavers to the inclusion criteria will NOT be allowed.
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.