Belatacept 3 Month Post Transplant Conversion Study
Condition: Transplant; Failure, Kidney; EBV
MeSH terms: Renal Insufficiency
Intervention: belatacept; Tacrolimus; MPA
Intervention description: Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention; Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention; Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
Intervention MeSH terms: Mycophenolic Acid; Abatacept; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney; Renal; Transplant; EBV; Immunosuppressants; Belatacept

Summary:

      This study is being done to investigate the impact of changing immunosuppressive medications
      from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months
      after kidney transplantation. The immune system is the body's defense against infection and
      other disease. After transplantation, the body sees the new organ as "foreign" and tries to
      destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from
      attacking the transplanted organ. The primary purpose of this research study is to evaluate
      the effects of three (3) different immunosuppressive treatments on rejection in
      post-transplant kidney recipients. This study will test whether switching from tacrolimus to
      belatacept will improve long-term kidney function.

      Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate
      mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug
      Administration (FDA) to be used after transplant. All of these medications have been
      routinely used in kidney recipients here at Northwestern University.

      Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant.
      However, the use of belatacept in this study is considered investigational as it has not been
      FDA approved for use beginning at 3 months after transplant.

      This study will involve 51 adult kidney transplant recipients at Northwestern.
    

Eligibility criteria:

        Inclusion Criteria

          1. Adult ≥ 18 years of age

          2. Male or Female

          3. EBV seropositive

          4. Recipient of renal transplant from living or deceased donor

        Exclusion Criteria

          1. Recipients with EBV serostatus negative or unknown

          2. History of acute rejection (AR) within 3 months prior to randomization

          3. History of positive donor specific antibodies (DSA)

          4. History of antibody mediated rejection

          5. Positive T-cell lymphocytotoxic cross match

          6. Proteinuria >1 g/day or > 0.5 g/day if diabetic

          7. Rejection on 3 month post-transplant screening biopsy

          8. BK nephropathy at 3 months post-transplant screening biopsy

          9. Positive pregnancy test at the time of randomization in female of child bearing
             potential

         10. History of previous transplant