Belatacept for Renal Transplant Recipients With Delayed Graft Function

Patients who undergo kidney transplantation require long term immunosuppressive therapy
(therapy that reduces your body's ability to respond to anything foreign) to prevent damage
to the graft, and some experience delayed graft function (DGF, a condition in which the
transplanted kidney does not function properly) after transplantation. This study is being
conducted to determine if kidney transplant recipients with delayed graft function (DGF) who
are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid
will recover from delayed graft function (DGF) in less time (which could potentially lower
the risk of rejection associated with delayed graft function) than kidney transplant
recipients with delayed graft function (DGF) who remain on the current standard
immunosuppressive regimen (standard of care).

Inclusion Criteria:

1. Signed Written Informed Consent

2. Deceased donor renal transplant recipient

3. Men and women, aged 18-60 years of age

Exclusion Criteria:

1. Seronegative or unknown EBV serostatus

2. Patients unwilling or incapable of providing informed consent.

3. Patients with active tuberculosis or positive TB test without evidence of infection
treatment.

4. Patients with demonstrated acute rejection on first biopsy evaluation for delayed
graft function; Second transplant or multiple organ transplant; patients more than 12
days post renal transplant prior to enrollment

5. Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for
study enrollment by the primary physician

6. Inadequate vein access to receive monthly IV infusions

7. Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or
Belatacept preventing therapy.

8. Pregnant women or women of child bearing age not willing to commit to dual
contraception prophylaxis

9. Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©)
are not permitted in this protocol; Use of other immunosuppressive agents must be
limited to those specified in this protocol.

10. Prisoners or subjects who are involuntarily incarcerated.

11. Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness.

12. Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or
class II