De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: A multicentre, open-label, randomized, controlled, non-inferiority trial

Kyu Ha Huh, Jae Geun Lee, Jongwon Ha, Chang Kwon Oh, Man Ki Ju, Chan Duck Kim, Hong Rae Cho, Cheol Woong Jung, Beom Jin Lim, Yu Seun Kim

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Most of the previous studies reported that tacrolimus (TAC) with sirolimus (SRL) was associated with worse post-transplant outcomes in kidney transplantation, compared with TAC with mycophenolate mofetil (MMF). These might be attributable to high-dose SRL. However, outcomes using low-dose SRL with TAC for kidney transplantation are uncertain. The aim of this study was to assess the efficacy and safety of low-dose SRL with extended-release tacrolimus (ER-TAC) versus MMF with ER-TAC. Methods We randomly assigned 158 renal transplant patients to receive low-dose SRL or MMF in combination with ER-TAC and corticosteroid. The primary endpoint was the composite efficacy failure rate, including biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up, within 12 months post-transplantation. This trial is registered with (number NCT01680952). Results The efficacy failure rate was 6.6% in the low-dose SRL group and 13.3% in the MMF group in the intention-to-treat population (absolute difference, 6.8%; 95% confidence interval, â '2.8% to 16.3%). The incidence of BPAR within 12 months post-transplantation was 5.3% in the low-dose SRL group and 13.3% in the MMF group (P = 0.09). The mean estimated glomerular filtration rate at 12 months post-transplantation was 53.2 mL/min/1.73 m 2 in the low-dose SRL group and 52.4 mL/min/1.73 m 2 in the MMF group (P = 0.76). The incidences of adverse events and serious adverse events were similar between groups. Conclusion Low-dose SRL with ER-TAC was not inferior to MMF with ER-TAC with respect to efficacy and safety. When used for immunosuppression in kidney transplantation, low-dose SRL with ER-TAC can effectively prevent acute rejection and preserve renal function.

Original languageEnglish
Pages (from-to)1415-1424
Number of pages10
JournalNephrology Dialysis Transplantation
Issue number8
Publication statusPublished - 2017 Aug 1


All Science Journal Classification (ASJC) codes

  • Nephrology
  • Transplantation

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