Bela 8 Week Dosing

The current dosing protocol for patients who have undergone a kidney transplant requires that
Belacept be given as an infusion every 4 weeks. The investigator wants to assess if the
patients who have been stable for one year after transplant can be safely transitioned to an
8-week Belatacept infusion schedule. Renal function and any episodes of acute rejection will
be closely monitored.

Inclusion Criteria:

- Adult (age ≥18 years currently),

- First-time renal transplant recipients of either living donor or deceased donor,

1. who were initiated on belatacept at the time of transplant and

2. are at least one year post-transplant and off CNI therapy for at least 6 months.

- Patients at low immunologic risk, defined as

1. patients with a first transplant who have a PRA < 50 against class I and class II
antigens,

2. no DSA (donor-specific antibodies),

3. who have not had more than one episode of rejection, and

4. no episodes of rejection within the last 6 months prior to enrollment, and

5. no rejection with a grade of IIB or above.

Exclusion Criteria:

- Not first renal transplant, or multi-organ transplant recipient

- History of greater than one episode of biopsy-proven acute rejection, or of rejection
of Banff 97 grade IIB or greater, or rejection within the last 6 months.

- Pregnancy (women of childbearing potential must use adequate contraception during
study)

- Unwilling to receive all belatacept infusions at the Emory Transplant Center

- Calculated Glomerular Filtration Rate (GFR) less than 35.

- Serum creatinine at enrollment over 30% higher than 3 months (±4 weeks) prior to
randomization

- HbA1C greater than 8 at enrollment

- Recent history of significant proteinuria (protein/Cr ratio >1)

- Non-standard belatacept dosing (e.g. dose other than 5 mg belatacept/kg body weight)

- Cellcept dose less than 500 mg po bid.

- Prednisone dose greater than 5mg po qd within 3 months of randomization

- Patients not currently taking prednisone

- Active infection, or antibiotic or antiviral drug therapy within 1 month of
randomization

- Evidence of Cytomegalovirus (CMV) viremia or clinical CMV infection within last 3
months.

- Polyomavirus BK PCR (polymerase chain reaction) load greater then 4.3 (copy number
greater than 20,0000) within 3 months of randomization

- Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing
not required)

- Known HIV (human immunodeficiency virus infection) (testing not required)

- Presence of donor specific antibody by Luminex single antigen assessment, or panel
reactivity (PRA) above 50%.

- History of substance abuse or psychiatric disorder not compatible with study adherence
and follow up.