Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (belatacept)-based Immunosuppression
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-36 months after kidney transplant.
January 01, 1900
Kidney/Dialysis - Kidney Transplant
Nelson Goes, M.D.
- Men and women, ages 18-75 inclusive
- Adult recipients of a renal allograft from a living donor or a deceased donor between 6-36 months prior to enrollment
- Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
- Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification of Diet in Renal Disease study (MDRD) 6 variable formula]
- No recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
- No history of acute rejection (AR) within 3 months prior to randomization
- No history of antibody mediated rejection
- No positive T-cell lymphocytotoxic cross match