SHS_610023 HARM CBRI 15101

Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression

Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit damage to or the possibility of rejecting the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.

Inclusion Criteria:

Men and women, aged 18 to 75.
Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+).
Diagnosed with end stage renal disease (ESRD) and scheduled to undergo transplantation of a non-HLA identical, living or standard criteria deceased donor kidney.

Exclusion Criteria:

Primary cause of ESRD is primary focal segmental glomerulosclerosis; or Type I or II membranoproliferative glomerulonephritis; or Hemolytic Uremic Syndrome / Thrombotic Thrombocytopenic Purpura.
Had a previous graft loss due to acute rejection.
At increased immunologic risk of graft loss due to panel reactive antibodies (PRA) >20% or need for desensitization therapy.
Scheduled to receive a: kidney from identical twin; or paired kidney; or kidney from a Cytomegalovirus(CMV) positive donor when recipient is CMV negative; or kidney from an extended criteria donor.
Have a body mass index (BMI) of > 35 kg/m2 for nondiabetics or > 30 kg/m^2 for diabetics.
Diagnosed as Hepatitis B positive; or Hepatitis C positive; or HIV positive; or currently or previously active or inadequately treated latent.
Phase II
NCT02137239
All Other
Kidney Transplant
Marquis Hart, M.D.
BMS (Bristol-Myers Squibb)
Julie Wallick
  • Swedish Medical Center