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A 39-month follow-up study to evaluate the safety and efficacy in kidney transplant recipients treated with modified-release tacrolimus (FK506E)-based immunosuppression regimen
DC Field | Value | Language |
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dc.contributor.author | 김유선 | - |
dc.date.accessioned | 2014-12-19T17:44:22Z | - |
dc.date.available | 2014-12-19T17:44:22Z | - |
dc.date.issued | 2012 | - |
dc.identifier.issn | 0041-1345 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/91964 | - |
dc.description.abstract | BACKGROUND: We initially performed a study to evaluate the safety and efficacy of modified-release tacrolimus (FK506E) in a phase 3, 2-arm, 6-month, randomized, open-label, multicenter trial in Korean living donor de novo kidney transplant recipients. We then performed an extended study to evaluate the long-term safety and efficacy of a FK506E-based regimen up to 45 months posttransplantation in recipients already treated with FK506E. METHODS: Initial study was designed as a randomized, open-label, comparative, multicenter study in de novo living donor kidney transplant recipients. The patients were randomized to an FK506E versus a control (FK506) group (1:1). Recipients who completed a 6-month FK506E treatment study were enrolled in the 39-month follow-up study. Primary end-points were patient and graft survivals at posttransplantation 45 months. Secondary end-point was the incidence of a clinical or biopsy-proven acute rejection episode between 6 and 45 months posttransplantation. RESULTS: In the initial 6-month de novo study 124 enrolled patients were randomized into either the FK506E (n = 62) or the control group (n = 62). The incidence of an acute rejection episode was 19.4% (n = 12) in the FK506E versus 16.1% (n = 10) in the control group (P = .638). There was no mortality or graft failure among the 44 recipients enrolled in this additional 39-month follow-up study. There was 1 patient with biopsy-proven acute cellular rejection episode (2.3%) who underwent steroid pulse therapy with renal function recovery. At the time of study completion 40/44 recipients (90.9%) maintained FK506E treatment. CONCLUSION: This 39-month study following the initial 6-month FK506E study period showed an FK506E-based immunosuppressive regimen in living donor kidney transplantation recipients to be safe and effective. | - |
dc.description.statementOfResponsibility | open | - |
dc.relation.isPartOf | TRANSPLANTATION PROCEEDINGS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | A 39-month follow-up study to evaluate the safety and efficacy in kidney transplant recipients treated with modified-release tacrolimus (FK506E)-based immunosuppression regimen | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Surgery (외과학) | - |
dc.contributor.googleauthor | D.J. Han | - |
dc.contributor.googleauthor | J.B. Park | - |
dc.contributor.googleauthor | Y.S. Kim | - |
dc.contributor.googleauthor | S.J. Kim | - |
dc.contributor.googleauthor | J. Ha | - |
dc.contributor.googleauthor | H.-C. Kim | - |
dc.contributor.googleauthor | S.-J. Kim | - |
dc.contributor.googleauthor | I.-S. Moon | - |
dc.contributor.googleauthor | C.-W. Yang | - |
dc.identifier.doi | 10.1016/j.transproceed.2011.12.070 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A00785 | - |
dc.relation.journalcode | J02755 | - |
dc.identifier.eissn | 1873-2623 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S0041134511017325 | - |
dc.contributor.alternativeName | Kim, Yu Seun | - |
dc.contributor.affiliatedAuthor | Kim, Yu Seun | - |
dc.citation.volume | 44 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 115 | - |
dc.citation.endPage | 117 | - |
dc.identifier.bibliographicCitation | TRANSPLANTATION PROCEEDINGS, Vol.44(1) : 115-117, 2012 | - |
dc.identifier.rimsid | 30033 | - |
dc.type.rims | ART | - |
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