Efficacy of Belatacept in Reducing DSA
Condition: Kidney Transplantation
Intervention: Belatacept
Intervention description: Patients will be converted from their MMF to Belatacept
Intervention MeSH terms: Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to demonstrate that administration of belatacept in
      maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody
      (DSA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipients of cadaveric, living related or living unrelated kidney transplant with
             positive DSA titer (two positive tests) and enrolled within 6 months of DSA detection.

          -  Patients with stable renal function. Stable renal function is defined as one serum
             creatinine (SCr) value that is +/- 10% of the baseline SCr within 3 months of
             enrollment (eGFR >/= 35 and </= 75 mL/min/1.73m^2).

          -  Patients who are EBV seropositive

          -  Males and females, 18-75 years of age;

          -  Patients currently receiving mycophenolic acid (MPA) (CellCept daily or myfortic
             daily), cyclosporine or tacrolimus with corticosteroids as part of their
             immunosuppressive regimen

          -  Patients willing to be converted to belatacept from cyclosporine or tacrolimus.

          -  Females of childbearing potential must have a negative pregnancy test prior to
             enrollment. The test should be performed at baseline visit. Effective contraception
             must be used during the trial, and for 4 weeks following discontinuation of the study
             medication;

          -  Patients who are willing and able to participate in the full course of the study and
             from whom written informed consent has been obtained.

        Exclusion Criteria:

          -  Multi-solid or cellular organ transplants (e.g. combined with pancreas, liver, islet,
             bone marrow), either concurrent or previous (with exception that a second kidney
             transplant is allowed);

          -  Evidence of graft rejection or treatment of acute rejection within 14 days prior to
             Baseline visit;

          -  Patients who have received any investigational drug within 4 weeks prior to study
             entry;

          -  Patients with HLA identical

          -  Patients who are Epstein-Barr virus (EBV) seronegative

          -  Presence of clinically significant infection requiring continued therapy, chronic
             infection (e.g. HIV, Hep B and Hep C), malignancy (within last 5 years, except excised
             squamous or basal cell carcinoma of the skin), lymphoma or renal toxicity that would
             interfere with the appropriate conduct of the study;

          -  Evidence of severe liver disease (incl. abnormal liver profile i.e. Aspartate
             Aminotransferase (AST), Alanine Aminotransferase (ALT) or total bilirubin >/= 3 times
             ULN) or severe diarrhea or active peptic ulcer disease that would interfere with the
             appropriate conduct of the study;

          -  Abnormal physical or laboratory findings of clinical significance within 2 weeks of
             inclusion which would interfere with the objectives of the study;

          -  Patients with symptoms of significant somatic or mental illness or evidence of drug
             and/or alcohol abuse;

          -  Patients receiving > 10 mg/day prednisone dose;

          -  History of hypersensitivity to any of the study drugs or to drugs with similar
             chemical structures to belatacept;

          -  Patients not making DSA antibodies;

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test (local); females of
             childbearing potential who are unwilling to use effective study-approved
             contraceptives and who are planning to become pregnant; Sexually active fertile men
             must use effective birth control if their partners are women of child bearing
             potential;

          -  Any other medical condition that, in the opinion of the site investigator based on
             recall or chart review would interfere with completing the study, including but not
             limited to visual problems or cognitive impairment.