Sirolimus conversion in liver transplant recipients with renal dysfunction: a prospective, randomized, single-center trial.

摘要: This pilot trial was designed to assess the safety and efficacy of SRL in liver transplant recipients with renal dysfunction. Forty patients dysfunction (24-hr CrCl 40-80 mL/min) were randomized be withdrawn from calcineurin inhibitor (CNI) receive sirolimus (SRL) or continue CNI (control arm). Improvement 24-hour seen arm at 3 months (75 mL/min vs. 56 control, P=0.012), whereas 12 there a trend toward improvement (72 58 P=0.09). Two patients, one each arm, developed steroid-sensitive rejection. Side effects limited included hyperlipidemia requiring treatment (15%), pruritus (5%), mouth sores (25%). In this trial, SRL-based immunosuppression safe alternative CNI. Although early improvements observed, withdrawing replacing it did not result statistically significant function follow-up.