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

Surendra Shenoy, Karen L. Hardinger, Jeffrey Crippin, Niraj Desai, Kevin Korenblat, Mauricio Lisker-Melman, Jeffrey A. Lowell, William Chapman

Research output: Contribution to journalArticlepeer-review

56 Scopus citations

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 Forty patients with renal dysfunction (24-hr CrCl 40-80 mL/min) were randomized to be withdrawn from the calcineurin inhibitor (CNI) and receive sirolimus (SRL) or to continue CNI (control arm).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%), pruritis (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.

Original languageEnglish
Pages (from-to)1389-1392
Number of pages4
JournalTransplantation
Volume83
Issue number10
DOIs
StatePublished - May 1 2007

Keywords

  • Liver transplantation
  • Renal toxicity
  • Sirolimus

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