Calcineurin Inhibitor–Free Mycophenolate Mofetil/Sirolimus Maintenance in Liver Transplantation: The Randomized Spare‐the‐Nephron Trial

摘要: Mycophenolate mofetil (MMF) and sirolimus (SRL) have been used for calcineurin inhibitor (CNI) minimization to reduce nephrotoxicity following liver transplantation. In this prospective, open-label, multicenter study, patients undergoing transplantation from July 2005 June 2007 who were maintained on MMF/CNI randomized 4 12 weeks after receive MMF/SRL (n = 148) or continue (n = 145) included in the intent-to-treat population. The primary efficacy endpoints mean percentage change calculated glomerular filtration rate (GFR) a composite of biopsy-proven acute rejection (BPAR), graft lost, death, lost follow-up months Patients followed median 519 days randomization. was associated with significantly greater renal function improvement baseline GFR 19.7 ± 40.6 (versus 1.2 ± 39.9 MMF/CNI, P = 0.0012). endpoint demonstrated noninferiority versus (16.4% 15.4%, 90% confidence interval = −7.1% 9.0%). incidence BPAR (12.2%) (4.1%, P = 0.02). Graft loss (including death) occurred 3.4% MMF/SRL-treated 8.3% MMF/CNI-treated (P = 0.04). Malignancy-related deaths less frequent MMF/SRL. Adverse events caused withdrawal 34.2% 24.1% (P = 0.06). use is an option transplant recipients can benefit improved but increased risk (but not loss). Liver Transpl 19:675–689, 2013.. © 2013 AASLD.