A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
Condition: Disorder Related to Renal Transplantation
Intervention: Thymoglobulin; Belatacept; Sirolimus; Tacrolimus; Mycophenolate Mofetil (MMF)
Intervention description: Induction therapy, IV infusion, All subjects will receive thymoglobulin 1.5-mg/kg i.v. infusion on Days 1 (day of transplant), 2, 3, and 4 (up to a maximum total dose of 6 mg/kg) i.v. infusion over at least 4 hours; Belatacept arms will receive i.v. belatacept (10 mg/kg) on Days 1 and 5, and then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, and 12), and then every 4 weeks through Month 6 (Weeks 16, 20, and 24). After 6 months, subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial; Sirolimus will be initiated at 5 mg/day on Day 1 (day of transplant) and continued through Day 2. The dosing will be adjusted subsequently to keep pre-dose (C0) levels at 7 - 12 ng/mL for the first 6 months, followed by 5 - 10 ng/mL thereafter; The recommended total initial dose of tacrolimus is 0.1 mg/kg/day in two divided doses orally up to and including week 52. Post week 52 subjects assigned to the tacrolimus arm will receive tacrolimus orally in accordance with local practice and the package insert until completion of the trial; Administered orally in a capsule or solution formulation in 2 divided doses on a consistent schedule in relation to time of day and meals. The dose should be 1 g bid; however 1.5 g bid may be administered at the investigator's discretion until completion of the trial
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Abatacept; Tacrolimus; Thymoglobulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Kidney transplant

Summary:

      The purpose of this clinical research study is to learn if belatacept (BMS-224818) is
      expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based
      immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The
      long-term safety and tolerability of belatacept based regimens following long-term
      administration in subjects who have received a kidney transplant
    

Eligibility criteria:

        Inclusion Criteria:

          -  Living or deceased donor renal allograft

          -  Men and women, 18 to 70 years old

          -  Subjects who have received a de novo kidney transplant, who have completed the initial
             study treatment through Month 12, and are willing to sign informed consent will be
             eligible to continue into the long term extension phase

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Epstein Barr Virus (EBV) negative serology

          -  First time renal transplant with panel reactive antibody (PRA) ≥ 50% or
             retransplantation with PRA > 30%

          -  Graft loss due to AR

          -  Positive T-cell or B-cell crossmatch

          -  Recipients/donors with HIV or hepatitis B/C

          -  Active tuberculosis (TB)

          -  Immunosuppressive therapy within 1 year of enrollment

          -  UNOS ECD organs will be excluded

          -  Body mass index (BMI) > 35 kg/m²

          -  Subjects who have developed any malignancy (other than non-melanoma skin cancer) or
             other medical condition that, in the investigator's opinion, should not be treated
             with an experimental immunosuppressive drug like belatacept