Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)

Exclusion Criteria

• •ABO blood group-incompatible renal allograft.
• •Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
• •Leukopenia or thrombocytopenia.
• •Positive for HIV-1, hepatitis B core antigen, or hepatitis C virus; or positivity for hepatitis B surface antigen.
• •Cardiac ejection fraction \< 40% or clinical evidence of insufficiency.
• •Forced expiratory volume FEV1 \< 50% of predicted.
• •Lactation or pregnancy.
• •History of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
• •Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type I or II membranoprolifertive glomerulonephritis).
• •Prior dose-limiting radiation therapy.
• •Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen.
• •Enrollment in other investigational drug studies within 30 days prior to enrollment.
• •Abnormal (\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
• •Allergy or sensitivity to any component of belatacept, ATG, tacrolimus, or rituximab.
• •Maintenance immunosuppression within 3 months prior to conditioning other than physiological doses of steroids, defined as ≤ 50 mg of hydrocortisone or dose equivalent.
• •The presence of any medical condition that the investigator deems incompatible with participation in the trial.