title: Sirolimus conversion in liver transplant recipients with renal dysfunction: a prospective, randomized, single-center trial.
abstract: This pilot trial was designed to assess the safety and efficacy of SRL in liver transplant recipients with renal dysfunction. Forty patients with renal dysfunction (24-hr CrCl 40-80 mL/min) were randomized to be withdrawn from the calcineurin inhibitor (CNI) and receive sirolimus (SRL) or to continue CNI (control arm). Improvement in 24-hour CrCl was seen in the SRL arm at 3 months (75 mL/min SRL vs. 56 mL/min control, P=0.012), whereas at 12 months there was a trend toward improvement in the SRL arm (72 mL/min SRL vs. 58 mL/min control, P=0.09). Two patients, one in each arm, developed steroid-sensitive rejection. Side effects of SRL were limited and included hyperlipidemia requiring treatment (15%), pruritus (5%), and mouth sores (25%). In this trial, SRL-based immunosuppression was a safe alternative to CNI. Although early improvements were observed, withdrawing CNI and replacing it with SRL did not result in a statistically significant improvement in renal function at 12 months of follow-up.
authors.affiliation: The Department of Surgery, Washington University, St Louis, MO 63110, USA. shenoysu@msnotes.wustl.edu
authors.forename: Surendra
authors.initials: S
authors.lastname: Shenoy
authors.forename: Karen L
authors.initials: KL
authors.lastname: Hardinger
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Crippin
authors.forename: Niraj
authors.initials: N
authors.lastname: Desai
authors.forename: Kevin
authors.initials: K
authors.lastname: Korenblat
authors.forename: Mauricio
authors.initials: M
authors.lastname: Lisker-Melman
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Lowell
authors.forename: William
authors.initials: W
authors.lastname: Chapman
mesh_terms: D000368:Aged; D002784:Cholesterol / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008077:Lipoproteins, LDL / Q000097:blood; D008111:Liver Function Tests; D016031:Liver Transplantation / Q000276:immunology* / Q000502:physiology; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D020123:Sirolimus / Q000493:pharmacokinetics / Q000627:therapeutic use*; D014280:Triglycerides / Q000097:blood
chemical_list: D007166:Immunosuppressive Agents; D008077:Lipoproteins, LDL; D014280:Triglycerides; D002784:Cholesterol; D020123:Sirolimus