This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Subject and renal allograft survival
Time frame: 52 weeks
Glomerular filtration rate
Time frame: 12 and 52 weeks
Change in glomerular filtration rate
Time frame: 12 weeks to 52 weeks
Transplant renal biopsies
Time frame: 52 weeks
Change in metabolic/cardiovascular risk factors
Time frame: 24 weeks and 52 weeks
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Repeating doses
Oral repeating dose