Inclusion Criteria:
- Male and female adolescents 12 to less than 18 years of age
- Recipients of a renal allograft from a living or deceased donor transplanted at least
6 calendar months prior to enrollment
- Receiving a stable regimen of a calcineurin inhibitor (CNI), with mycophenolate
mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil
(EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior to
randomization
- Clinically stable renal function during the 12-week period prior to screening, in the
opinion of the investigator and based on protocol-defined criteria for proteinuria and
estimated glomerular filtration rate (eGFR)
- Serologic evidence of past exposure to Epstein-Barr virus (EBV) and current absence of
EBV DNA replication at or prior to renal transplantation and during the Screening
period
- Completion of an initial course of SARS-CoV-2 vaccination per local standard of care,
a minimum of 6 weeks prior to enrollment
Exclusion Criteria:
- Recipients with EBV serostatus negative or unknown at screening or at transplant
- Treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6
calendar months prior to enrollment
- Biopsy-confirmed antibody-mediated acute rejection at any time with the current
allograft
- Banff 97 grade IIA or higher acute cellular rejection (or equivalent), or treatment
with plasmapheresis or rituximab for any acute rejection at any time with the current
allograft
- Current evidence or past history of active or inadequately treated latent tuberculosis
(TB) infection
- Previously treated with belatacept or previously enrolled in a belatacept trial with
their present allograft
Other inclusion/exclusion criteria apply
Recruiting
