Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Genentech, Inc.
Treatments:
Antibodies, Monoclonal
Basiliximab
Cyclosporine
Cyclosporins
Immunosuppressive Agents
Mycophenolate mofetil
Mycophenolic Acid