A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen in De Novo Renal Transplantation

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.

Key Inclusion Criteria:

• Have signed the informed consent form and the HIPAA patient information form (United States only)
• Are ≥ 18 years of age
• Are a transplant recipient of at least one HLA-mismatch kidney
• For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method

Key Exclusion Criteria:

• Have a history of previous renal transplant
• Have had a PRA > 25% at any time
• Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ
• Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum
• Have had previous treatment with efalizumab
• Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer
• Have a known contraindication to efalizumab
• Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies
• Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab
• Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate