Belatacept in Kidney Transplantation of Moderately Sensitized Patients

Exclusion Criteria

• •Patient has previously received an organ transplant other than a kidney.
• •Patient is receiving an human leukocyte antigen (HLA) identical living donor transplant
• •Patient who is a recipient of a multiple organ transplant
• •Patient with a positive T or B cell crossmatch
• •Patient with a donor specific antibody (DSA) as deemed by the local PI to be associated with significant risk of rejection
• •Patient has received an ABO incompatible donor kidney
• •Recipients will be receiving a dual or en bloc kidney transplant
• •Donor anticipated cold ischemia is \> 30hours
• •Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive. HCV seropositive patients with a negative HCV viral load testing may be included.
• •Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
• •Seronegative or unknown EBV serostatus
• •Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
• •Patients with tuberculosis who have not been treated for latent infection.
• •Patients at high risk for polyoma virus-associated nephropathy, which is mostly due to BK virus infection
• •Patients at high risk for polyoma virus-associated nephropathy, which is mostly due to BK virus infection
• •Patients with thrombocytopenia (PLT \<75,000/mm3), and/or leucopoenia (WBC \< 2,000/mm3), or anemia (hemoglobin \< 6 g/dL) prior to study inclusion.
• •Patient is taking or has been taking an investigational drug in the 30 days prior to transplant
• •Patient who has undergone desensitization therapy within 6 months prior to transplant
• •Patient has a known hypersensitivity to belatacept, tacrolimus, mycophenolate mofetil, alemtuzumab, rabbit anti-thymocyte globulin, or glucocorticoids
• •Patient is receiving chronic steroid therapy at the time of transplant
• •Patients with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years
• •Patients with \> Grade 2 peripheral neuropathy within 14 days before enrollment
• •Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiography evidence of acute ischemia or active conduction system abnormalities.
• •Female subject is pregnant or breast-feeding
• •Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
• •Prisoners or subjects who are involuntarily incarcerated