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临床试验/NCT01496703
NCT01496703已完成不适用

Reasons for Dose Reduction of Mycophenolate Mofetil During the First Post-transplant Year in Renal Transplant Recipients and Its Impact on Graft Outcome: a Single-center Retrospective Analysis

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 749 人开始时间: 1996年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
749
试验地点
1
主要终点
reasons for dose reduction of MMF

研究概览

简要总结

Mycophenolate mofetil (MMF) decreases the risk of acute rejection and is associated with improved graft survival in renal transplant recipients. However, MMF-related side effects often necessitate dose reduction which may expose transplant recipients to a higher risk of acute rejection and graft loss. This study's aim was to examine the reasons for MMF dose reduction during the first year after kidney transplantation and its impact on acute rejection, overall and death-censored graft loss. Methods: Retrospective electronic file based analysis of all patients who underwent a single kidney transplantation in our center between 1996 and 2007 and were treated with MMF as part of their initial maintenance immunosuppressive protocol (n=749).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who received a single renal transplant at the University Hospitals of Leuven between April 1996 (when MMF was introduced in the Leuven renal transplant program) and February 2007 and were treated with MMF (Cellcept®, Roche) as part of their initial maintenance immunosuppressive regimen were included in this retrospective analysis.

排除标准

  • If a patient underwent more than one kidney transplantation in the abovementioned 11-year period, only the last was considered.

结局指标

主要结局

reasons for dose reduction of MMF

时间窗: 400 days post-transplantation

次要结局

  • occurence of acute rejection(400 days post-transplantation)
  • graft survival(400 days post-transplantation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bert Bammens

Clinical Professor, Principal Investigator

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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