Tacrolimus Monotherapy in Liver Transplantation: One-Year Results of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study. Tacrolimus Monotherapy in Liver Transplantation: One-Year Results of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study.From the *Department of Abdominal and Transplantation Surgery-Unit of Abdominal Transplantation, Departments of daggerPathology and double daggerRadiology, section signLaboratory of Immunohematology, paragraph signLaboratory of Pharmatherapeutical Monitoring, parallelDepartment of Intensive Care, and **Laboratory of Experimental Surgery (CHEX), UniversitA© catholique de Louvain Cliniques Universitaires Saint-Luc, Brussels, Belgium.BACKGROUND:: Minimal immunosuppression (IS) is desirable in organ transplantation to reduce side effects and to promote the process of tolerance induction. MATERIAL AND METHODS:: Between February 2000 and September 2004, 156 adults ( 15 years old) receiving a primary liver graft were enrolled in a prospective, randomized, double-blind, placebo-controlled, investigator-driven single-center study comparing tacrolimus (TAC)-placebo (PL) and TAC-low-dose, short-term (64 days) steroid (ST) IS. There were no exclusion criteria at moment of randomization. All patients had a 12-month follow-up (range, 12-84). RESULTS:: Three- and 12-month patient survival rates were 93.6% and 87.2% in the TAC-PL group and 98.7% and 94.7% in TAC-ST group (P = 0.096 and P = 0.093, respectively). Three- and 12-month graft survival rates were 92.3% and 85.9% versus 97.4% and 92.3% (P = 0.14 and 0.13, respectively). By 3 and 12 months, rejection treatment had been given in 20.5% (16 pts) and 23% (18 pts) of TAC-PL patients and in 12.7% (10 pts) and 20.5% (16 pts) of TAC-ST patients (P = 0.20 and 0.54). Corticosteroid-resistant rejection (CRR) at 3 and 12 months was recorded in 12.8% (10 pts) of TAC-PL patients and 3.8% (3 pts) of TAC-ST patients (P = 0.04).