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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

Authors
Huh, Kyu HaLee, Jae GeunHa, JongwonOh, Chang-KwonJu, Man KiKim, Chan-DuckCho, Hong RaeJung, Cheol WoongLim, Beom JinKim, Yu Seun
Issue Date
8월-2017
Publisher
OXFORD UNIV PRESS
Keywords
kidney transplantation; mycophenolate; mofetil; post-transplant outcome; sirolimus; tacrolimus
Citation
NEPHROLOGY DIALYSIS TRANSPLANTATION, v.32, no.8, pp.1415 - 1424
Indexed
SCIE
SCOPUS
Journal Title
NEPHROLOGY DIALYSIS TRANSPLANTATION
Volume
32
Number
8
Start Page
1415
End Page
1424
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/82664
DOI
10.1093/ndt/gfx093
ISSN
0931-0509
Abstract
Background. 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 ClinicalTrial.gov (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, -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 12months post-transplantation was 53.2mL/min/1.73 m(2) in the low-dose SRL group and 52.4mL/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.
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