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 trialopen access
- Authors
- Huh, Kyu Ha; Lee, Jae Geun; Ha, Jongwon; Oh, Chang-Kwon; Ju, Man Ki; Kim, Chan-Duck; Cho, Hong Rae; Jung, Cheol Woong; Lim, Beom Jin; Kim, Yu Seun; RECORD Study; Kim, Myung Gyu(RECORD Study)
- Issue Date
- Aug-2017
- Publisher
- Oxford University Press
- Keywords
- kidney transplantation; mycophenolate; mofetil; post-transplant outcome; sirolimus; tacrolimus
- Citation
- Nephrology Dialysis Transplantation, v.32, no.8, pp 1415 - 1424
- Pages
- 10
- Indexed
- SCI
SCIE
SCOPUS
- Journal Title
- Nephrology Dialysis Transplantation
- Volume
- 32
- Number
- 8
- Start Page
- 1415
- End Page
- 1424
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/4757
- DOI
- 10.1093/ndt/gfx093
- ISSN
- 0931-0509
1460-2385
- 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 12 months post-transplantation was 53.2 mL/min/1.73 m2 in the low-dose SRL group and 52.4 mL/min/1.73 m2 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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- Appears in
Collections - 2. Clinical Science > Department of Nephrology and Hypertension > 1. Journal Articles
- 2. Clinical Science > Department of Transplantation and Vascular Surgery > 1. Journal Articles
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