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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 |
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dc.contributor.author | 김유선 | - |
dc.contributor.author | 이재근 | - |
dc.contributor.author | 임범진 | - |
dc.contributor.author | 주만기 | - |
dc.contributor.author | 허규하 | - |
dc.date.accessioned | 2018-07-20T07:43:02Z | - |
dc.date.available | 2018-07-20T07:43:02Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 0931-0509 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/160456 | - |
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 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.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Oxford University Press | - |
dc.relation.isPartOf | NEPHROLOGY DIALYSIS TRANSPLANTATION | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Case-Control Studies | - |
dc.subject.MESH | Dose-Response Relationship, Drug | - |
dc.subject.MESH | Equivalence Trials as Topic | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Glomerular Filtration Rate | - |
dc.subject.MESH | Graft Rejection/drug therapy | - |
dc.subject.MESH | Graft Rejection/etiology | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunosuppressive Agents/therapeutic use | - |
dc.subject.MESH | Kidney Transplantation/adverse effects | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Mycophenolic Acid/therapeutic use | - |
dc.subject.MESH | Sirolimus/therapeutic use | - |
dc.subject.MESH | Tacrolimus/therapeutic use | - |
dc.subject.MESH | Time Factors | - |
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.college | College of Medicine | - |
dc.contributor.department | Dept. of Surgery | - |
dc.contributor.googleauthor | Kyu Ha Huh | - |
dc.contributor.googleauthor | Jae Geun Lee | - |
dc.contributor.googleauthor | Jongwon Ha | - |
dc.contributor.googleauthor | Chang-Kwon Oh | - |
dc.contributor.googleauthor | Man Ki Ju | - |
dc.contributor.googleauthor | Chan-Duck Kim | - |
dc.contributor.googleauthor | Hong Rae Cho | - |
dc.contributor.googleauthor | Cheol Woong Jung | - |
dc.contributor.googleauthor | Beom Jin Lim | - |
dc.contributor.googleauthor | Yu Seun Kim | - |
dc.identifier.doi | 10.1093/ndt/gfx093 | - |
dc.contributor.localId | A00785 | - |
dc.contributor.localId | A03068 | - |
dc.contributor.localId | A03363 | - |
dc.contributor.localId | A03949 | - |
dc.contributor.localId | A04344 | - |
dc.relation.journalcode | J02316 | - |
dc.identifier.eissn | 1460-2385 | - |
dc.identifier.pmid | 28810721 | - |
dc.identifier.url | https://academic.oup.com/ndt/article/32/8/1415/3894559 | - |
dc.subject.keyword | kidney transplantation | - |
dc.subject.keyword | mofetil | - |
dc.subject.keyword | mycophenolate | - |
dc.subject.keyword | post-transplant outcome | - |
dc.subject.keyword | sirolimus | - |
dc.subject.keyword | tacrolimus | - |
dc.contributor.alternativeName | Kim, Yu Seun | - |
dc.contributor.alternativeName | Lee, Jae Geun | - |
dc.contributor.alternativeName | Lim, Beom Jin | - |
dc.contributor.alternativeName | Joo, Man Ki | - |
dc.contributor.alternativeName | Huh, Kyu Ha | - |
dc.contributor.affiliatedAuthor | Kim, Yu Seun | - |
dc.contributor.affiliatedAuthor | Lee, Jae Geun | - |
dc.contributor.affiliatedAuthor | Lim, Beom Jin | - |
dc.contributor.affiliatedAuthor | Joo, Man Ki | - |
dc.contributor.affiliatedAuthor | Huh, Kyu Ha | - |
dc.citation.volume | 32 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 1415 | - |
dc.citation.endPage | 1424 | - |
dc.identifier.bibliographicCitation | NEPHROLOGY DIALYSIS TRANSPLANTATION, Vol.32(8) : 1415-1424, 2017 | - |
dc.identifier.rimsid | 42292 | - |
dc.type.rims | ART | - |
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