Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure.
Anthony Jevnikar, Dianne Arlen, Brendan Barrett, Anne Boucher, Carl Cardella, Sandra M Cockfield, David Rush, Steven Paraskevas, Jean Shapiro, Ahmed Shoker, Serdar Yilmaz, Jeffrey S Zaltzman, Bryce Kiberd
{"title":"Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure.","authors":"Anthony Jevnikar, Dianne Arlen, Brendan Barrett, Anne Boucher, Carl Cardella, Sandra M Cockfield, David Rush, Steven Paraskevas, Jean Shapiro, Ahmed Shoker, Serdar Yilmaz, Jeffrey S Zaltzman, Bryce Kiberd","doi":"10.1097/TP.0b013e318186dd0c","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Chronic allograft nephropathy is the most frequent cause of long-term kidney allograft loss. Studies are desperately needed to improve long-term survival. Tacrolimus has been associated with less rejection and better kidney function compared with cyclosporine in clinical trials. This study tested the hypothesis that conversion from cyclosporine to tacrolimus might improve long-term outcomes in patients with chronic allograft damage.</p><p><strong>Methods: </strong>In this multicenter Canadian clinical trial, cyclosporine-treated patients with biopsy-proven chronic allograft nephropathy and impaired renal function were randomly assigned (2:1) to convert to tacrolimus or continue on cyclosporine therapy. A total of 106 (70 tacrolimus and 36 cyclosporine treated) patients were followed-up for up to 5 years. The primary outcome was graft survival.</p><p><strong>Results: </strong>In an intention to treat analysis, subsequent graft (73% vs. 81%, P=0.2835, log-rank test) and patient survival (91% vs. 92%, P=0.8668, log-rank test) were not different between the tacrolimus and cyclosporine groups, respectively. Changes in Chronic Allograft Damage Index scores on protocol biopsies from baseline to 3 years were not different (+0.4+/-1.8 vs. +1.3+/-3.2, P=0.5910, cyclosporine vs. tacrolimus, respectively). There were no significant differences in biopsy-proven acute rejection (6 [8.6%] vs. 2 [5.6%], tacrolimus vs. cyclosporine, respectively, P=0.5906).</p><p><strong>Conclusions: </strong>In this study, patients with chronic allograft damage converted from cyclosporine to tacrolimus demonstrated no apparent benefit.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":"86 7","pages":"953-60"},"PeriodicalIF":5.3000,"publicationDate":"2008-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1097/TP.0b013e318186dd0c","citationCount":"8","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Transplantation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/TP.0b013e318186dd0c","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 8
Abstract
Background: Chronic allograft nephropathy is the most frequent cause of long-term kidney allograft loss. Studies are desperately needed to improve long-term survival. Tacrolimus has been associated with less rejection and better kidney function compared with cyclosporine in clinical trials. This study tested the hypothesis that conversion from cyclosporine to tacrolimus might improve long-term outcomes in patients with chronic allograft damage.
Methods: In this multicenter Canadian clinical trial, cyclosporine-treated patients with biopsy-proven chronic allograft nephropathy and impaired renal function were randomly assigned (2:1) to convert to tacrolimus or continue on cyclosporine therapy. A total of 106 (70 tacrolimus and 36 cyclosporine treated) patients were followed-up for up to 5 years. The primary outcome was graft survival.
Results: In an intention to treat analysis, subsequent graft (73% vs. 81%, P=0.2835, log-rank test) and patient survival (91% vs. 92%, P=0.8668, log-rank test) were not different between the tacrolimus and cyclosporine groups, respectively. Changes in Chronic Allograft Damage Index scores on protocol biopsies from baseline to 3 years were not different (+0.4+/-1.8 vs. +1.3+/-3.2, P=0.5910, cyclosporine vs. tacrolimus, respectively). There were no significant differences in biopsy-proven acute rejection (6 [8.6%] vs. 2 [5.6%], tacrolimus vs. cyclosporine, respectively, P=0.5906).
Conclusions: In this study, patients with chronic allograft damage converted from cyclosporine to tacrolimus demonstrated no apparent benefit.
背景:慢性同种异体移植肾病是导致长期同种异体移植肾丧失的最常见原因。迫切需要研究来提高长期生存率。在临床试验中，与环孢素相比，他克莫司具有更少的排斥反应和更好的肾功能。本研究验证了从环孢素到他克莫司的转换可能改善慢性同种异体移植物损伤患者的长期预后的假设。方法:在这项加拿大多中心临床试验中，接受环孢素治疗的活检证实的慢性同种异体移植肾病和肾功能受损患者被随机分配(2:1)，转用他克莫司或继续环孢素治疗。106例患者(他克莫司组70例，环孢素组36例)随访5年。主要结局是移植物存活。结果:在意向治疗分析中，他克莫司组和环孢素组的术后移植(73% vs 81%， P=0.2835，对数秩检验)和患者生存率(91% vs 92%， P=0.8668，对数秩检验)均无差异。从基线到3年，方案活检的慢性同种异体移植物损伤指数评分的变化没有差异(环孢素与他克莫司分别为+0.4+/-1.8 vs +1.3+/-3.2, P=0.5910)。活检证实的急性排斥反应(6例[8.6%]对2例[5.6%]，他克莫司与环孢素，P=0.5906)无显著差异。结论:在这项研究中，慢性同种异体移植物损伤患者从环孢素转为他克莫司没有明显的益处。
期刊介绍：
The official journal of The Transplantation Society, and the International Liver Transplantation Society, Transplantation is published monthly and is the most cited and influential journal in the field, with more than 25,000 citations per year.
Transplantation has been the trusted source for extensive and timely coverage of the most important advances in transplantation for over 50 years. The Editors and Editorial Board are an international group of research and clinical leaders that includes many pioneers of the field, representing a diverse range of areas of expertise. This capable editorial team provides thoughtful and thorough peer review, and delivers rapid, careful and insightful editorial evaluation of all manuscripts submitted to the journal.
Transplantation is committed to rapid review and publication. The journal remains competitive with a time to first decision of fewer than 21 days. Transplantation was the first in the field to offer CME credit to its peer reviewers for reviews completed.
The journal publishes original research articles in original clinical science and original basic science. Short reports bring attention to research at the forefront of the field. Other areas covered include cell therapy and islet transplantation, immunobiology and genomics, and xenotransplantation.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
