Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

Phase: 
IV

Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

The main purpose of this study is to find out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.

Are you Eligible? (Inclusion Criteria)

Inclusion Criteria:

  • Patients must have known Epstein-Barr virus (EBV) serostatus, and that status must be positive
  • Adult patients ≥18 years of age, receiving a deceased donor kidney transplant at Columbia University Medical Center (CUMC)
  • Primary or re-transplant candidates (no more than 3rd renal transplant)
  • Women of reproductive age who are willing to delay pregnancy for the duration of the study and use appropriate recommended contraception

Exclusion Criteria:

  • Seronegative or unknown EBV serologic status (due to the risk of post-transplant lymphoproliferative disorder (PTLD) predominately involving the central nervous system).
  • Patients with tuberculosis who have not been treated for latent infection.
  • Scheduled to undergo a multi-organ transplantation
  • Dual kidney transplantation
  • Recipients of previous non-renal organ transplant
  • ABO incompatible renal transplant
  • History or known HIV, Hepatitis B virus (surface antigen) or Hepatitis C virus positive.
  • Known hypersensitivity or contra-indications to belatacept, Tacrolimus, Mycophenolate sodium
  • Enrollment in an interventional clinical trial other than the current
  • Presence of clinically significant infections requiring continued therapy
  • Lactating or pregnant women

Specialty Area(s)

Trial Location

Columbia University Medical Center
New York, NY 10032
United States