This study will examine the safety and effectiveness of a combination kidney and bone marrow
transplant from a haplo-identical related donor. An investigational medication and other
treatments will be given prior to and after the transplant to help protect the transplanted
kidney from being attacked by the body's immune system
- Male or female 18-60 years of age
- Candidate for a living-donor renal allograft from an HLA mismatched donor
- First or second transplant with either a living donor or cadaveric transplant as the
- Use of FDA-approved methods of contraception by all recipients from the time that
study treatment begins until 104 weeks (24 months) after renal transplantation.
- Ability to understand and provide informed consent.
- Serologic evidence of prior exposure to EBV.
- 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
- Underlying renal disease etiology with a high risk of disease recurrence in the
transplanted kidney (such as focal segmental glomerulosclerosis, type I or II
- 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
- 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
- The presence of any medical condition that the investigator deems incompatible with
participation in the trial.