Bela 8 Week Dosing
Condition: Kidney Transplantation
Intervention: Belatacept
Intervention description: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Intervention MeSH terms: Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Immunosuppression; Transplantation Immunology

Summary:

      The purpose of this study is to transition patients who have been stable on Belatacept for
      one year after kidney transplant from standard 4-week to an investigational 8-week belatacept
      dosing schedule. The investigators hypothesize that renal function and acute rejection rates
      will be non-inferior with 8-week belatacept dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (age ≥18 years currently),

          -  First-time renal transplant recipients of either living donor or deceased donor,

               1. who were initiated on belatacept at the time of transplant and

               2. are at least one year post-transplant and off CNI therapy for at least 6 months.

          -  Patients at low immunologic risk, defined as

               1. patients with a first transplant who have a PRA < 50 against class I and class II
                  antigens,

               2. no DSA (donor-specific antibodies),

               3. who have not had more than one episode of rejection, and

               4. no episodes of rejection within the last 6 months prior to enrollment, and

               5. no rejection with a grade of IIB or above.

        Exclusion Criteria:

          -  Not first renal transplant, or multi-organ transplant recipient

          -  History of greater than one episode of biopsy-proven acute rejection, or of rejection
             of Banff 97 grade IIB or greater, or rejection within the last 6 months.

          -  Pregnancy (women of childbearing potential must use adequate contraception during
             study)

          -  Unwilling to receive all belatacept infusions at the Emory Transplant Center

          -  Calculated Glomerular Filtration Rate (GFR) less than 35.

          -  Serum creatinine at enrollment over 30% higher than 3 months (±4 weeks) prior to
             randomization

          -  HbA1C greater than 8 at enrollment

          -  Recent history of significant proteinuria (protein/Cr ratio >1)

          -  Non-standard belatacept dosing (e.g. dose other than 5 mg belatacept/kg body weight)

          -  Cellcept dose less than 500 mg po bid.

          -  Prednisone dose greater than 5mg po qd within 3 months of randomization

          -  Patients not currently taking prednisone

          -  Active infection, or antibiotic or antiviral drug therapy within 1 month of
             randomization

          -  Evidence of Cytomegalovirus (CMV) viremia or clinical CMV infection within last 3
             months.

          -  Polyomavirus BK PCR (polymerase chain reaction) load greater then 4.3 (copy number
             greater than 20,0000) within 3 months of randomization

          -  Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing
             not required)

          -  Known HIV (human immunodeficiency virus infection) (testing not required)

          -  Presence of donor specific antibody by Luminex single antigen assessment, or panel
             reactivity (PRA) above 50%.

          -  History of substance abuse or psychiatric disorder not compatible with study adherence
             and follow up.