Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
Condition: Graft Rejection; Kidney Transplantation; Renal Transplantation
Intervention: Belatacept; Cyclosporine; Mycophenolate mofetil (MMF); Corticosteroids
Intervention description: Solution, intravenous; Oral, capsule; Oral, capsule; Corticosteroids given daily, orally or intravenously (IV). Day of transplant (Day 1): methylprednisolone, 500 mg, given IV on arrival in operating room; Day 2: methylprednisolone, 250 mg, given IV once daily; Day 3: prednisone, 100 mg, given orally once daily; Day 4: prednisone, 50 mg, given orally once daily; Days 5 through 30: prednisone, 25 mg, given orally once daily; Days 31-44: prednisone, 22.5 mg, given orally once daily; Days 45-58: prednisone, 20 mg, given orally once daily
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Abatacept; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: kidney; transplant; rejection

Summary:

      The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is
      as efficacious as treatment with cyclosporine at preventing acute rejection and with a
      superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid
      problems, less diabetes mellitus).
    

Eligibility criteria:

        Key inclusion criteria

          -  Recipients of first kidney transplant

        Key exclusion criteria

          -  Those at high risk for acute allograft rejection, including those who receive a second
             or more renal transplant, those with a history of panel reactive antibody levels >20%,
             and those considered by investigators to be at relatively higher risk for acute
             rejection

          -  Human leukocyte antigen-identical donor-recipient pairs

          -  Cold ischemia time >36 hours (donor kidney)

          -  Participants who are positive for hepatitis C antibody, on polymerase chain reaction,
             for hepatitis B surface antigen, and for human immunodeficiency virus

          -  A positive purified protein derivative tuberculosis test (test performed within 1 year
             of enrollment), unless previously vaccinated with Bacille-Calmette-Guérin or those who
             had a history of adequate chemoprophylaxis

          -  Any active infection that would normally exclude transplantation

          -  Recipients of multiple organ transplants

          -  Donor age >60 or <6 years or donors whose hearts were not beating

          -  Recipients with underlying renal disease of (due to risk of rapid disease recurrence
             in the allograft): focal segmental glomerulosclerosis, Type I or II
             membranoproliferative glomerulonephritis, or hemolytic uremic syndrome/ thrombotic
             thrombocytopenic purpura

          -  A positive T-cell lymphocytoxic crossmatch using donor lymphocytes and recipient serum

          -  A history of true allergy to intravenous iodinated roentgenographic contrast agents

          -  Participants with life expectancy severely limited by disease state or other
             underlying medical condition

          -  A history of cancer (other than nonmelanoma skin cell cancers cured by local
             resection) within the last 5 years

          -  Mammogram film with any clinically significant abnormality requiring further
             investigation or biopsies

          -  History of substance abuse (drug or alcohol) or psychotic disorders that were not
             compatible with adequate study follow-up

          -  A currently functioning, nonrenal transplant

          -  Previous treatment with basiliximab for any reason

          -  Active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption

          -  Those who had used any investigational drug within 30 days before the Day 1 visit.