Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China (REACH)
The primary objective of this study is to evaluate graft survival and recipient survival among kidney transplant recipients in China, and also to analyze possible factors related to patient and graft survival.
The secondary objective is to evaluate several secondary outcomes among kidney transplant recipients, such as average creatinine value, acute rejection episodes, NODM, incidence of BKV infection etc. At the same time analyze possible impact factors related to these secondary outcomes.
研究概览
地位
条件
详细说明
Renal transplantation is the choice for patients with end-stage renal disease. In the past two decades, progress in surgical procedure, medical care, and immunosuppression have significantly improved the short-term results of organ transplantation. Nevertheless, grafts continue to fail over time, these improvements in immunosuppression and reduced incidence of acute rejection episodes have had only minimal effects on chronic allograft dysfunction and late graft loss. Long-term patient's death and graft failure are the main limitations for a better performance of renal transplant programs.
Multiple factors have been shown to affect the outcome of renal transplantation. These include demographic characteristics such as race and ethnicity, pretransplantation dialysis course, the timing of the transplantation,and the patients' co morbidities. Patient response to the transplantation procedure (e.g., delayed graft function, acute rejection, and acute tubular necrosis) is strongly associated with the long-term prognosis. In the last decade, with the increase of immunosuppressive agents in our therapeutic arsenal, several attempts have been made to improve graft performance. However, the majority of trials aiming to avoid calcineurin inhibitor (CNI)-related nephrotoxicity only reported short-term data. Also, and because of the lack of assessment of the role of the different ethiopathogenic factors that lead to graft damage, just avoiding CNI-related nephrotoxicity may be an oversimplification of the problem in the prevention of graft attrition.
There are many studies which have evaluated the long-term outcomes of graft and patient survival and have analyzed multiple relative factors. Unfortunately, such data in Chinese population are lacking. Meanwhile, the situation in China is somewhat different with others, such as race, the dosage of immunosuppressant and so on. A better characterization of the weight of immune and non-immune factors responsible for graft damage may help us to improve the outcomes in transplant recipients. Studies derived from well-designed and well-performed patient registries can provide a real world view of clinical practice, patient outcomes, safety, and comparative effectiveness and cost effectiveness. The goal of this project is to analyze retrospective data collected by disease registry, then to evaluate the graft and recipient outcomes of kidney transplants and relative impact factors.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100034
- Peking University First Hospital
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Beijing、Beijing、中国、100853
- Chinese PLA General Hospital
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Beijing、Beijing、中国、100000
- The 309th Hospital of Chinese People's Liberation Army
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Beijing、Beijing、中国、100020
- Beijing ChaoYang Hospital
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Beijing、Beijing、中国、100050
- Beijing Friendship Hospital
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Fujian
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Fuzhou、Fujian、中国、350025
- Fuzhou General hospital of Nanjing Military Command
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Guangdong
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Guangzhou、Guangdong、中国、510080
- The First Affiliated Hospital Sun Yat-Sen University
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Guangzhou、Guangdong、中国、510599
- Nanfang Hospital
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Henan
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Zhengzhou、Henan、中国、450052
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan、Hubei、中国、430030
- Tongji Hospital
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Hunan
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Changsha、Hunan、中国、410000
- The Second Xiangya Hospital of Central South University
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Liaoning
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Shenyang、Liaoning、中国
- Shenyang Military General Hospital
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Shandong
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Jinan、Shandong、中国、250000
- Jinan Military General Hospital
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Shanghai
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Shanghai、Shanghai、中国、200032
- Zhongshan Hospital Fudan University
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Shanghai、Shanghai、中国、200080
- Shanghai First People's Hospital
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Shanxi
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Xian、Shanxi、中国、710061
- First Affiliated Hospital Of Medical College of Xian Jiaotong University
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Sichuan
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Chengdu、Sichuan、中国、610041
- West China Hospital,Sichuan University
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Zhejiang
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Hangzhou、Zhejiang、中国、310003
- The First Affiliated Hospital, Zhejiang University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Kidney transplant recipients
- Received a transplant from Jan 1,1995 to Dec 31, 2007, only including those with living donor grafts
- Age: 18-75 years
Exclusion Criteria:
- Multiple-organ transplant recipients
- Patients records with missing information in 12 months post-transplantation
- Patients who did not have the information regarding their maintenance immunosuppressive therapy
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:追溯
队列和干预
团体/队列 |
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kidney transplantation patients with living-donor grafts
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Graft survival
大体时间:5-year
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Graft survival, measured as the time between kidney transplant and the failure of the graft.
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5-year
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Recipient survival
大体时间:5-year
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measured as the time between the most recent kidney transplant and the patient's death.
Graft outcome was censored at the earliest of the following events and was analyzed as days to graft failure or censor: loss to follow-up, patient death.
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5-year
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次要结果测量
结果测量 |
大体时间 |
---|---|
Average creatinine value
大体时间:5 years
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5 years
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The rate of acute rejection episodes
大体时间:5 years
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5 years
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The incidence of BPAR and its severity
大体时间:5 years
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5 years
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The incidence of NODM
大体时间:5 years
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5 years
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The incidence of infection
大体时间:5 years
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5 years
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The incidence of biopsy proven CNIs nephrotoxicity
大体时间:5 years
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5 years
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The rate of posttransplantation malignancies
大体时间:5 years
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5 years
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- COLO400ACN02
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