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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

DC Field Value Language
dc.contributor.author김유선-
dc.contributor.author이재근-
dc.contributor.author임범진-
dc.contributor.author주만기-
dc.contributor.author허규하-
dc.date.accessioned2018-07-20T07:43:02Z-
dc.date.available2018-07-20T07:43:02Z-
dc.date.issued2017-
dc.identifier.issn0931-0509-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/160456-
dc.description.abstractBackground: 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.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherOxford University Press-
dc.relation.isPartOfNEPHROLOGY DIALYSIS TRANSPLANTATION-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHCase-Control Studies-
dc.subject.MESHDose-Response Relationship, Drug-
dc.subject.MESHEquivalence Trials as Topic-
dc.subject.MESHFemale-
dc.subject.MESHGlomerular Filtration Rate-
dc.subject.MESHGraft Rejection/drug therapy-
dc.subject.MESHGraft Rejection/etiology-
dc.subject.MESHHumans-
dc.subject.MESHImmunosuppressive Agents/therapeutic use-
dc.subject.MESHKidney Transplantation/adverse effects-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHMycophenolic Acid/therapeutic use-
dc.subject.MESHSirolimus/therapeutic use-
dc.subject.MESHTacrolimus/therapeutic use-
dc.subject.MESHTime Factors-
dc.titleDe 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.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Surgery-
dc.contributor.googleauthorKyu Ha Huh-
dc.contributor.googleauthorJae Geun Lee-
dc.contributor.googleauthorJongwon Ha-
dc.contributor.googleauthorChang-Kwon Oh-
dc.contributor.googleauthorMan Ki Ju-
dc.contributor.googleauthorChan-Duck Kim-
dc.contributor.googleauthorHong Rae Cho-
dc.contributor.googleauthorCheol Woong Jung-
dc.contributor.googleauthorBeom Jin Lim-
dc.contributor.googleauthorYu Seun Kim-
dc.identifier.doi10.1093/ndt/gfx093-
dc.contributor.localIdA00785-
dc.contributor.localIdA03068-
dc.contributor.localIdA03363-
dc.contributor.localIdA03949-
dc.contributor.localIdA04344-
dc.relation.journalcodeJ02316-
dc.identifier.eissn1460-2385-
dc.identifier.pmid28810721-
dc.identifier.urlhttps://academic.oup.com/ndt/article/32/8/1415/3894559-
dc.subject.keywordkidney transplantation-
dc.subject.keywordmofetil-
dc.subject.keywordmycophenolate-
dc.subject.keywordpost-transplant outcome-
dc.subject.keywordsirolimus-
dc.subject.keywordtacrolimus-
dc.contributor.alternativeNameKim, Yu Seun-
dc.contributor.alternativeNameLee, Jae Geun-
dc.contributor.alternativeNameLim, Beom Jin-
dc.contributor.alternativeNameJoo, Man Ki-
dc.contributor.alternativeNameHuh, Kyu Ha-
dc.contributor.affiliatedAuthorKim, Yu Seun-
dc.contributor.affiliatedAuthorLee, Jae Geun-
dc.contributor.affiliatedAuthorLim, Beom Jin-
dc.contributor.affiliatedAuthorJoo, Man Ki-
dc.contributor.affiliatedAuthorHuh, Kyu Ha-
dc.citation.volume32-
dc.citation.number8-
dc.citation.startPage1415-
dc.citation.endPage1424-
dc.identifier.bibliographicCitationNEPHROLOGY DIALYSIS TRANSPLANTATION, Vol.32(8) : 1415-1424, 2017-
dc.identifier.rimsid42292-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers

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