Conditions: Immunosuppression in Solid Organ Transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: Other arm 5: None

Interventions: intervention 1: Tacrolimus intervention 2: Basiliximab intervention 3: Belatacept More Intensive (MI) intervention 4: Belatacept Less Intensive (LI) intervention 5: Mycophenolate Mofetil (MMF)
Intervention descriptions: intervention 1: Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\]) intervention 2: Intravenous (IV), 20 mg, Day1 and Day 5 intervention 3: Intravenous (IV),

10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24.

After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\]) intervention 4: Intravenous (IV),

10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12.

After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE) intervention 5: Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])

Protocol document: