Sirolimus conversion regimen versus continued calcineurin inhibitors in liver allograft recipients: a randomized trial.

Journal Article (Journal Article)

A large prospective, open-label, randomized trial evaluated conversion from calcineurin inhibitor (CNI)- to sirolimus (SRL)-based immunosuppression for preservation of renal function in liver transplantation patients. Eligible patients received liver allografts 6-144 months previously and maintenance immunosuppression with CNI (cyclosporine or tacrolimus) since early posttransplantation. In total, 607 patients were randomized (2:1) to abrupt conversion (<24 h) from CNI to SRL (n = 393) or CNI continuation for up to 6 years (n = 214). Between-group changes in baseline-adjusted mean Cockcroft-Gault GFR at month 12 (primary efficacy end point) were not significant. The primary safety end point, noninferiority of cumulative rate of graft loss or death at 12 months, was not met (6.6% vs. 5.6% in the SRL and CNI groups, respectively). Rates of death at 12 months were not significantly different, and no true graft losses (e.g. liver transplantation) were observed during the 12-month period. At 52 weeks, SRL conversion was associated with higher rates of biopsy-confirmed acute rejection (p = 0.02) and discontinuations (p < 0.001), primarily for adverse events. Adverse events were consistent with known safety profiles. In conclusion, liver transplantation patients showed no demonstrable benefit 1 year after conversion from CNI- to SRL-based immunosuppression.

Full Text

Duke Authors

Cited Authors

  • Abdelmalek, MF; Humar, A; Stickel, F; Andreone, P; Pascher, A; Barroso, E; Neff, GW; Ranjan, D; Toselli, LT; Gane, EJ; Scarola, J; Alberts, RG; Maller, ES; Lo, C-M; Sirolimus Liver Conversion Trial Study Group,

Published Date

  • March 2012

Published In

Volume / Issue

  • 12 / 3

Start / End Page

  • 694 - 705

PubMed ID

  • 22233522

Electronic International Standard Serial Number (EISSN)

  • 1600-6143

Digital Object Identifier (DOI)

  • 10.1111/j.1600-6143.2011.03919.x


  • eng

Conference Location

  • United States