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
DC Field | Value | Language |
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dc.contributor.author | Huh, Kyu Ha | - |
dc.contributor.author | Lee, Jae Geun | - |
dc.contributor.author | Ha, Jongwon | - |
dc.contributor.author | Oh, Chang-Kwon | - |
dc.contributor.author | Ju, Man Ki | - |
dc.contributor.author | Kim, Chan-Duck | - |
dc.contributor.author | Cho, Hong Rae | - |
dc.contributor.author | Jung, Cheol Woong | - |
dc.contributor.author | Lim, Beom Jin | - |
dc.contributor.author | Kim, Yu Seun | - |
dc.date.accessioned | 2021-09-03T03:23:21Z | - |
dc.date.available | 2021-09-03T03:23:21Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017-08 | - |
dc.identifier.issn | 0931-0509 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/82664 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | OXFORD UNIV PRESS | - |
dc.subject | RENAL-ALLOGRAFT SURVIVAL | - |
dc.subject | RAPAMYCIN INHIBITORS | - |
dc.subject | MAMMALIAN TARGET | - |
dc.subject | IMMUNOSUPPRESSION | - |
dc.subject | REGIMENS | - |
dc.subject | TACROLIMUS/MYCOPHENOLATE | - |
dc.subject | CANCER | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Jung, Cheol Woong | - |
dc.identifier.doi | 10.1093/ndt/gfx093 | - |
dc.identifier.scopusid | 2-s2.0-85026856246 | - |
dc.identifier.wosid | 000406752700022 | - |
dc.identifier.bibliographicCitation | NEPHROLOGY DIALYSIS TRANSPLANTATION, v.32, no.8, pp.1415 - 1424 | - |
dc.relation.isPartOf | NEPHROLOGY DIALYSIS TRANSPLANTATION | - |
dc.citation.title | NEPHROLOGY DIALYSIS TRANSPLANTATION | - |
dc.citation.volume | 32 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 1415 | - |
dc.citation.endPage | 1424 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Transplantation | - |
dc.relation.journalResearchArea | Urology & Nephrology | - |
dc.relation.journalWebOfScienceCategory | Transplantation | - |
dc.relation.journalWebOfScienceCategory | Urology & Nephrology | - |
dc.subject.keywordPlus | RENAL-ALLOGRAFT SURVIVAL | - |
dc.subject.keywordPlus | RAPAMYCIN INHIBITORS | - |
dc.subject.keywordPlus | MAMMALIAN TARGET | - |
dc.subject.keywordPlus | IMMUNOSUPPRESSION | - |
dc.subject.keywordPlus | REGIMENS | - |
dc.subject.keywordPlus | TACROLIMUS/MYCOPHENOLATE | - |
dc.subject.keywordPlus | CANCER | - |
dc.subject.keywordAuthor | kidney transplantation | - |
dc.subject.keywordAuthor | mycophenolate | - |
dc.subject.keywordAuthor | mofetil | - |
dc.subject.keywordAuthor | post-transplant outcome | - |
dc.subject.keywordAuthor | sirolimus | - |
dc.subject.keywordAuthor | tacrolimus | - |
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