Belatacept Early Steroid Withdrawal Trial

Inclusion Criteria

• Male and female patients > 18 years of age.
• Patient who is receiving a renal transplant from a living or deceased donor.
• Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
• The patient has given written informed consent to participate in the study.

Exclusion Criteria

• Patient has previously received an organ transplant other than a kidney.
• Patient is receiving an human leucocyte antigen (HLA) identical living donor transplant.
• Patient who is a recipient of a multiple organ transplant.
• Patient has a most recent cytotoxic panel reactive antibody (PRA) of >25% or calculated PRA of > 50% where multiple moderate level HLA antibodies exist and in the opinion of the PI represents substantial HLA sensitization.
• Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies.
• Patient with a donor specific antibody (DSA) as deemed by the local PI to be associated with significant risk of rejection.
• Patient has received a blood group (ABO) incompatible donor kidney.
• The donor and/or donor kidney meet any of the following extended criteria for organ donation (ECD):
• Donor age >/= 60 years OR
• Donor age 50-59 years and 1 of the following:
• Cerebrovascular accident (CVA) + hypertension + serum creatinine (SCr) > 1.5 mg/dL OR
• CVA + hypertension OR
• CVA + SCr > 1.5 mg/dL OR
• Hypertension + SCr > 1.5 mg/dL OR
• Cold ischemia time (CIT) > 24 hours, donor age > 10 years OR
• Donation after cardiac death (DCD)
• Recipients will be receiving a dual or en bloc kidney transplant.
• Donor anticipated cold ischemia is > 30 hours.
• Recipient that is seropositive for hepatitis C virus (HCV) with detectable Hepatitis C viral load are excluded. HCV seropositive patients with a negative HCV viral load testing may be included.
• Recipients who are Hepatitis B core antibody seropositive are eligible if their hepatitis B viral loads are negative. After transplant, their hepatitis B viral loads will be monitored every three months for the first year after transplant. If hepatitis B viral loads become positive, patients will be treated per institutional standard of care.
• Patients who are Hepatitis B surface antibody seropositive and who receive a kidney from a Hepatitis B core surface antibody positive donor may be included.
• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
• Recipient who is seronegative for Epstein Barr virus (EBV).
• Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
• Patients with thrombocytopenia (PLT 95%.
• Patient is pregnant, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
• Women of childbearing potential must use reliable contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
• Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
• Inability to cooperate or communicate with the investigator.