Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
Condition: Kidney Transplant
Intervention: Belatacept
Intervention description: Single intravenous infusion of belatacept, 7.5 mg/kg
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate how well adolescent kidney transplant patients
      tolerate a single dose of belatacept they receive at least 6 months after transplant surgery,
      and how their body handles the drug.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male and Female subjects,12-17 years old

          -  Receiving CNI-based maintenance immunosuppression since the time of renal
             transplantation in accordance with local standard of care

          -  Stable renal function, in the opinion of the investigator, with a cGFR>45
             mL/min/1.73m2 at the time of enrollment (per updated Schwartz Formula)

          -  Adolescent Recipients of a renal allograft from a living donor or a deceased donor at
             least 6 months prior to enrollment

          -  Subject must be receiving a calcineurin inhibitor (CNI)-based [cyclosporine (CsA) [any
             formulation] or Tacrolimus (TAC)] immunosuppressive regimen

          -  Subject must be receiving adjunctive background maintenance immunosuppression with
             mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium
             (EC-MPS)/mycophenolic acid (MPA)

          -  Subjects may be receiving maintenance corticosteroids in accordance with the local
             standard of care

          -  Negative Interferon Gamma Release Assay (IGRA) such as QuantiFERON-TB Gold test or
             T-Spot-TB

          -  FOCBP must have negative serum or urine pregnancy test within 24 hrs prior to start of
             study medication

          -  Subject must have stable estimated glomerular filtration rate (GFR) ≥45 mL/min/1.73m2
             (updated Schwartz formula)

        Exclusion Criteria:

          -  Epstein-Barr virus (EBV) serostatus negative or unknown at time of transplant and
             screening

          -  History of any treated or biopsy proven acute rejection (BPAR) within 3 months prior
             to enrollment

          -  Subjects who have experienced more than 1 episode of acute rejection (AR) of the
             current allograft or any antibody-mediated AR

          -  Subjects with any active infection [including, but not limited to, positive
             cytomegalovirus (CMV) or BK viral (BKV) loads, BKV associated nephropathy (BKVAN), CMV
             retinitis, CMV colitis, etc.]

          -  Urine albumin:creatinine ratio > 56.5 mg/mmol (> 0.5 mg albumin / mg creatinine) on a
             random voided urine specimen