Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

Taking standard anti-rejection medications for a long time can cause serious side effects,
including kidney damage. Transplant recipients have to take anti-rejection medications to
prevent their immune system (the body's natural defense system against illness) from
rejecting their new kidney. Most patients who receive a kidney transplant must take these
anti-rejection medications for the rest of their lives, or for as long as the kidney
continues to work.

The purpose of this study is to determine if NULOJIX® (belatacept), will minimize serious
long term side effects seen with anti-rejection medications while still protecting the
transplanted kidney from damage. The researchers also want to learn more about the safety of
this treatment and the long term health of the transplanted kidney.

Inclusion Criteria:

- Male or Female, 18-65 years of age at the time of enrollment;

- Ability to understand and provide written informed consent;

- Candidate for primary renal allograft from either living or deceased donor;

- No known contraindications to study therapy using NULOJIX® (belatacept);

- Female participants of childbearing potential must have a negative pregnancy test upon
study entry;

- Participants with reproductive potential must agree to use an appropriate method(s) of
birth control as outlined in the CellCept® , Myfortic® or generic package labeling
during participation in the study and for 4 months following completion of the study;

- No donor specific antibodies prior to transplant that are considered to be of clinical
significance by the site investigator;

- Negative crossmatch or Panel Reactive Antibodies (PRA) of 0% on historic and current
sera, as determined by each participating study center;

- A documented negative tuberculosis (TB) test within the 6 months prior to transplant.
If documentation is not present at the time of transplantation, and the subject does
not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA)
may be performed.

Exclusion Criteria:

- Need for multi-organ transplant;

- Recipient of previous organ transplant;

- Epstein-Barr Virus (EBV) seronegative (or unknown) recipients;

- Active infection including hepatitis B, hepatitis C, or human Immunodeficiency Virus
(HIV);

- Individuals who have required treatment with prednisone or other immunosuppressive
drugs within 1 year prior to transplant;

- Individuals undergoing transplant using organs from extended criteria donor (ECD) or
donation after cardiac death (DCD) donors;

- Histocompatibility antigen (HLA) identical living donors;

- Individuals at significant risk of early recurrence of the primary renal disease
including focal segmental glomerulosclerosis (FSGS) and membranoproliferative
glomerulonephritis (MPGN) type 2 or any other disease that in the opinion of the
investigator is at increased likelihood of recurrence and which may result in rapid
decline in renal function;

- Known history of thrombotic events or risk factors, including any of the following:

- Factor V Leiden, elevated homocysteine, positive lupus anticoagulant, elevated
anticardiolipin antibody, heparin-induced thrombocytopenia,

- A family history of a heritable thrombotic condition,

- Recurrent deep vein thrombosis (DVT) or pulmonary emboli (PE),

- Unexplained stillborn infant or recurrent spontaneous abortion or other
congenital or acquired thrombotic disorder.

At the discretion of the investigator, a history of thrombosis of a dialysis access graft,
fistula, or indwelling catheter/device may not be considered an exclusion criterion.

- Any condition that, in the opinion of the investigator, would interfere with the
participant's ability to comply with study requirements;

- Use of investigational drugs within 4 weeks of enrollment;

- Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;

- Administration of live attenuated vaccine(s) within 8 weeks of enrollment;

- Blood type A2 and A2B donors into blood type B recipients.