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 journalArticle

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 Forty patients with renal dysfunction (24-hr CrCl 40-80 mL/min) were randomized to be withdrawn from the calcineurin inhibitor (CNI) and receive sirolimus (SRL) or to continue CNI (control arm).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 (US)
Pages (from-to)1389-1392
Number of pages4
JournalTransplantation
Volume83
Issue number10
DOIs
StatePublished - May 1 2007
Externally publishedYes

Keywords

  • Liver transplantation
  • Renal toxicity
  • Sirolimus

ASJC Scopus subject areas

  • Transplantation

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    Shenoy, S., Hardinger, K. L., Crippin, J., Desai, N., Korenblat, K., Lisker-Melman, M., Lowell, J. A., & Chapman, W. (2007). Sirolimus conversion in liver transplant recipients with renal dysfunction: A prospective, randomized, single-center trial. Transplantation, 83(10), 1389-1392. https://doi.org/10.1097/01.tp.0000261630.63550.41