临床试验/NCT06348446

NCT06348446招募中不适用

Tacrolimus Exposure and Outcomes in Kidney Transplant Patients: A Retrospective Multicenter Study of Clinical Data Warehouse (CDW) in South Korea

Seoul National University Hospital4 个研究点分布在 1 个国家目标入组 12,000 人开始时间: 2022年2月1日最近更新: 2024年4月4日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Seoul National University Hospital
入组人数: 12,000
试验地点: 4
主要终点: relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation.

研究设计

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

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers
•Patients receiving oral tacrolimus as one of the main immunosuppressant at the start of the defined cohort time (i.e. at post-transplant 2 months for the analysis of 1-year outcomes and at post-transplant 12 months for the analysis of 6-year outcomes)

排除标准

•Graft failure occurring within the first 2 month of transplantation
•Mortality of any cause occurring within the first 2 month of transplantation
•Patients moving centers during the study period
•Patients who have received other organ transplantation(s) besides renal transplantation in the defined period

结局指标

主要结局

relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes

时间窗: 1 year after transplantation

the relationship between time varying periodic mean of tacrolimus trough level during 2-12 mo. post-transplant and a composite of 1-year allograft outcomes consisting of biopsy proven acute rejection, renal dysfunction (eGFR\<30), development of dnDSA, and death censored graft failure that occurred within 1 year from the latest transplant.

次要结局

relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event(6 year after transplantation)
relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality(6 year after transplantation)
relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome(6 year after transplantation)
relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection(6 year after transplantation)

研究者

发起方

Seoul National University Hospital

申办方类型

Other

责任方

Sponsor

研究点 (4)

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