Sirolimus conversion in liver transplant recipients with renal dysfunction: a prospective, randomized, single-center trial.
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 Forty patients with renal dysfunction (24-hr CrCl 40-80 mL/min) were randomized to be withdrawn from the calcineurin inhibitor (CNI) and receive sirolimus (SRL) or to continue CNI (control arm).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.
Shenoy
Surendra
S
The Department of Surgery, Washington University, St Louis, MO 63110, USA. shenoysu@msnotes.wustl.edu
Hardinger
Karen L
KL
Crippin
Jeffrey
J
Desai
Niraj
N
Korenblat
Kevin
K
Lisker-Melman
Mauricio
M
Lowell
Jeffrey A
JA
Chapman
William
W
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
D007166:Immunosuppressive Agents; D008077:Lipoproteins, LDL; D014280:Triglycerides; D002784:Cholesterol; D020123:Sirolimus