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In a phase III, open-label, comparative, noninferiority study, 638 subjects receiving de novo kidney transplants were randomized to one of three treatment arms: tacrolimus extended-release (Astagraf XL) qd, tacrolimus (Prograf) bid, or cyclosporine (CsA) bid. All subjects received basiliximab induction, mycophenolate mofetil, and corticosteroids. Safety and efficacy follow-up data through 4 years are reported.

transplantation

Long-Term Follow-Up of a Phase III Clinical Trial Comparing Tacrolimus Extended-Release/MMF, Tacrolimus/MMF, and Cyclosporine/MMF in De Novo Kidney Transplant Recipients