Efficacy of Belatacept in Reducing DSA

The aim of this study is to evaluate patients converted to belatacept in combination with
MMF with corticosteroids with respect to their DSA titer. Patients in this study will be
converted from their CNI to belatacept from baseline in an attempt to down-modulate antibody
production by B-cells. Dosing will be calculated per prescribing information for dosing
maintenance phase (5mg per kg every 28 days.

Inclusion Criteria:

- Recipients of cadaveric, living related or living unrelated kidney transplant with
positive DSA titer (two positive tests) and enrolled within 6 months of DSA
detection.

- Patients with stable renal function. Stable renal function is defined as one SCr
value that is +/- 10% of the baseline SCR within 3 months of enrollment (eGFR >/= 35
and
- Patients who are EBV seropositive

- Males and females, 18-75 years of age;

- Patients currently receiving MPA (CellCept daily or myfortic daily), cyclosporine or
tacrolimus with corticosteroids as part of their immunosuppressive regimen

- Patients willing to be converted to belatacept from cyclosporine or tacrolimus.

- Females of childbearing potential must have a negative pregnancy test prior to
enrollment. The test should be performed at baseline visit. Effective contraception
must be used during the trial, and for 4 weeks following discontinuation of the study
medication;

- Patients who are willing and able to participate in the full course of the study and
from whom written informed consent has been obtained.

Exclusion Criteria:

- Multi-solid or cellular organ transplants (e.g. combined with pancreas, liver, islet,
bone marrow), either concurrent or previous (with exception that a second kidney
transplant is allowed);

- Evidence of graft rejection or treatment of acute rejection within 14 days prior to
Baseline visit;

- Patients who have received any investigational drug within 4 weeks prior to study
entry;

- Patients with HLA identical

- Patients who are EBV seronegative

- Presence of clinically significant infection requiring continued therapy, chronic
infection (e.g. HIV, Hep B and Hep C), malignancy (within last 5 years, except
excised squamous or basal cell carcinoma of the skin), lymphoma or renal toxicity
that would interfere with the appropriate conduct of the study;

- Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total
bilirubin >/= 3 times ULN) or severe diarrhea or active peptic ulcer disease that
would interfere with the appropriate conduct of the study;

- Abnormal physical or laboratory findings of clinical significance within 2 weeks of
inclusion which would interfere with the objectives of the study;

- Patients with symptoms of significant somatic or mental illness or evidence of drug
and/or alcohol abuse;

- Patients receiving > 10 mg/day prednisone dose;

- History of hypersensitivity to any of the study drugs or to drugs with similar
chemical structures to belatacept;

- Patients not making DSA antibodies;

- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test (local); females of childbearing potential who are
unwilling to use effective study-approved contraceptives and who are planning to
become pregnant; Sexually active fertile men must use effective birth control if
their partners are women of child bearing potential;

- Any other medical condition that, in the opinion of the site investigator based on
recall or chart review would interfere with completing the study, including but not
limited to visual problems or cognitive impairment.