Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients
Condition: Implant or Graft; Rejection
MeSH terms: Delayed Graft Function
Intervention: Belatacept; Tacrolimus; Mycophenolate; rATG; Methylprednisolone; Renal transplant
Intervention description: Belatacept 10 mg/kg will be administered in the operating room approximately 1 hour prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: Day 5, 14, 30, 56, and 84.
Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study.; Tacrolimus 0.05 mg/kg by mouth every 12 hours will be on Day 0 after transplantation. It will then be administered at 8-12 ng/mL on the following post-transplantation days: Day 3-90; at 8-10 ng/mL Day 91-180.
Tacrolimus 6 - 8 ng/mL will be administered daily thereafter until end of study.
(standard of care); An immunosuppressive agent used with other medicines to lower the body's natural immunity in patients who receive kidney transplants.
720 mg by mouth every 12 hours (Day 0)(1080 mg AA).
(standard of care); 1.5 mg/kg IV daily on Day 0-3.
(standard of care); 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3.
(standard of care); Standard organ transplant of a kidney into a patient with end-stage renal disease.
Intervention MeSH terms: Methylprednisolone; Abatacept; Tacrolimus; Antilymphocyte Serum; Thymoglobulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: kidney; renal; transplant; belatacept; delayed graft function; thymoglobulin; tacrolimus; kidney function; immunosuppression; NGAL

Summary:

      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.
    

Eligibility 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)

          -  Patients with a PRA ≤ of 50

          -  Primary or re-transplant candidates (no more than 5th renal transplant)

          -  Deceased donor renal transplant recipients

          -  Candidates eligible for rATG induction

          -  Patients fully consented prior to transplantation

          -  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), predominantly involving the central nervous
             system.

          -  Patients with tuberculosis who have not been treated for latent infection.

          -  Scheduled to undergo multi-organ transplantation

          -  Recipients of previous non-renal organ transplant

          -  Patient receiving 5th renal transplant at the time of screening.

          -  Patients with a PRA > 50

          -  Recipient is pre-emptive status.

          -  Recipient with positive flow crossmatch.

          -  History or known HIV

          -  Known hypersensitivity or contra-indications to Belatacept, Tacrolimus, Mycophenolate
             mofetil (cellcept), or mycophenolic acid

          -  Use of an investigational drug in the past 30 days before day of surgery

          -  Enrolled in a clinical trial other than the current

          -  Lactating or pregnant women

          -  Donor specific antibodies (DSA) identified at the time of transplantation

          -  ABO incompatible renal transplant