A prospective, randomized trial of FK 506/prednisone vs FK 506/azathioprine/prednisone in renal transplant patients.

FK 506 (Tacrolimus-Prograf) was first used clinically in February 1989.1 and approved by the United States Food and Drug Administration in April 1994 as a new immunosuppressive agent for use after liver transplantation.2-4 It has also been utilized as the primary immunosuppressive agent after heart.5 lung,6 intestinal7 and islet8 transplantation. In renal transplantation, it has been studied extensively as a primary and rescue agent in adults and children at a single center, the University of Pittsburgh9-12; it also has been studied as a primary agent in multicenter trials in Japan, Europe, and the United States.13,14 The most recent publications from the University of Pittsburgh have reported on a prospective, randomized trial comparing two FK 506-based regimens, with and without azathioprine.10 This report presents, for the first time, results with all 397 cases entered into this trial.