Tacrolimus (FK 506) is a novel immunosuppressive agent that has been i
n clinical use for solid organ transplantation since 1989. Early clini
cal trials of tacrolimus in liver, heart, kidney, lung, and intestinal
transplantation at the University of Pittsburgh have demonstrated it
to be a safe and effective agent with several potential advantages ove
r existing immunosuppressive drugs. More recently, phase I and II mult
icenter trials of tacrolimus for renal transplantation have been perfo
rmed; however, data are not yet available from these trials. Our exper
ience with this drug has demonstrated excellent 1- and 2-year actuaria
l graft survival rates of 89% and 83%, respectively, in adult renal tr
ansplantation and 1- and 3-year graft survival rates of 98% and 85%, r
espectively in pediatric renal transplantation. A major advantage of t
acrolimus noted in these trials was the ability to discontinue steroid
therapy in approximately 50% of the patients. Tacrolimus has also sho
wn efficacy as a rescue agent for renal allograft rejection failing co
nventional therapy in 74% of cases. This paper expands on these observ
ations and focuses on the experience we have gained with the use of ta
crolimus at our institution over the last 6 years.