Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients

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www.BMSStudyConnect.com

Inclusion Criteria:

- Male and Female subjects,12-17 years old

- Receiving CNI-based maintenance immunosuppression since the time of renal
transplantation in accordance with local standard of care

- Stable renal function, in the opinion of the investigator, with a cGFR>45
mL/min/1.73m2 at the time of enrollment (per updated Schwartz Formula)

- Adolescent Recipients of a renal allograft from a living donor or a deceased donor at
least 6 months prior to enrollment

- Subject must be receiving a calcineurin inhibitor (CNI)-based [cyclosporine (CsA)
[any formulation] or Tacrolimus (TAC)] immunosuppressive regimen

- Subject must be receiving adjunctive background maintenance immunosuppression with
mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium
(EC-MPS)/mycophenolic acid (MPA)

- Subjects may be receiving maintenance corticosteroids in accordance with the local
standard of care

- Negative Interferon Gamma Release Assay (IGRA) such as QuantiFERON-TB Gold test or
T-Spot-TB

- FOCBP must have negative serum or urine pregnancy test within 24 hrs prior to start
of study medication

- Subject must have stable estimated glomerular filtration rate (GFR) ≥45 mL/min/1.73m2
(updated Schwartz formula)

Exclusion Criteria:

- Epstein-Barr virus (EBV) serostatus negative or unknown at time of transplant and
screening

- History of any treated or biopsy proven acute rejection (BPAR) within 3 months prior
to enrollment

- Subjects who have experienced more than 1 episode of acute rejection (AR) of the
current allograft or any antibody-mediated AR

- Significant proteinuria

- Active infection