Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores

Inclusion Criteria:

- Male or female renal recipients 18-70 years of age undergoing primary kidney
transplantation.

- Recipients of deceased donor (including expanded criteria donor organs and deceased
donor organs after cardiac death) with MAPI score ≥ 8.

- Cold ischemic time less than 40 hours at time of reperfusion.

- Negative serum pregnancy test for female patients.

- Patients who can understand the purposes and risks of the study, provide informed
consent, and can comply with the treatment and follow-up requirements.

Exclusion Criteria:

- Cold ischemic time (CIT) > 40 hours

- Patients who are sensitized with current PRA>40%, ABO incompatible transplants, or T,
or B cell crossmatch positive transplant.

- Patients without antibody to EBV

- Patients receiving multiple organ transplants.

- Patients unable to take oral medication at time of randomization

- Patient with a history of malignancy of any organ system, treated or untreated, within
the past 2 years whether or not there is evidence of local recurrence or metastases,
with the exception of carcinoma in situ

- Patients who tested positive for HIV, Hepatitis C or Hepatitis B surface antigen.

- Recipients of organs from donors who test positive for HIV, Hepatitis C or Hepatitis B
surface antigen

- Patients with a clinically significant systemic infection within 30 days prior to
transplant

- Patients who have cardiac failure at time of screening or any other severe cardiac
disease as determined by the investigator

- Patients with abnormal laboratory findings of clinical significance within 2 weeks of
randomization which would interfere with the objectives of the study.

- Females, pregnant or lactating, or are of childbearing potential unwilling to use an
effective means of contraception or are planning to become pregnant.

- Patient with active tuberculosis infection