Conditions: De Novo Kidney Transplantation
Keywords: kidney transplant alefacept
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 218
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.

Detailed description:

Arms:
arm 1: Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. arm 2: Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.

Interventions: intervention 1: Alefacept intervention 2: placebo intervention 3: Tacrolimus intervention 4: Mycophenolate Mofetil intervention 5: Steroids
Intervention descriptions: intervention 1: IV and subcutaneous injection intervention 2: IV and subcutaneous injection intervention 3: The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery. intervention 4: Mycophenolic mofetil was administered as 750 mg twice per day orally intervention 5: Methylprednisolone or equivalent:

Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus

Prednisone or equivalent:

Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally

Protocol document: