5456W-13: BMS Nulojix Immunosuppression

Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (belatacept)-based Immunosuppression

Type of Study
Kidney/Dialysis - Kidney Transplant
Location
Transplant Program
Short Description
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.
Status
OPEN
Principal Investigator
Nelson Goes, M.D.
Eligibility Notes
  • 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
Contact Name
Terri Spinelli
Phone
(206) 215-3063
Email
Teri.Spinelli@swedish.org