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Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China (REACH)

2014年6月17日 更新者:Novartis

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

完全的

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

观察性的

注册 (实际的)

1500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beijing
      • Beijing、Beijing、中国、100034
        • Peking University First Hospital
      • Beijing、Beijing、中国、100853
        • Chinese PLA General Hospital
      • Beijing、Beijing、中国、100000
        • The 309th Hospital of Chinese People's Liberation Army
      • Beijing、Beijing、中国、100020
        • Beijing ChaoYang Hospital
      • Beijing、Beijing、中国、100050
        • Beijing Friendship Hospital
    • Fujian
      • Fuzhou、Fujian、中国、350025
        • Fuzhou General hospital of Nanjing Military Command
    • Guangdong
      • Guangzhou、Guangdong、中国、510080
        • The First Affiliated Hospital Sun Yat-Sen University
      • Guangzhou、Guangdong、中国、510599
        • Nanfang Hospital
    • Henan
      • Zhengzhou、Henan、中国、450052
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan、Hubei、中国、430030
        • Tongji Hospital
    • Hunan
      • Changsha、Hunan、中国、410000
        • The Second Xiangya Hospital of Central South University
    • Liaoning
      • Shenyang、Liaoning、中国
        • Shenyang Military General Hospital
    • Shandong
      • Jinan、Shandong、中国、250000
        • Jinan Military General Hospital
    • Shanghai
      • Shanghai、Shanghai、中国、200032
        • Zhongshan Hospital Fudan University
      • Shanghai、Shanghai、中国、200080
        • Shanghai First People's Hospital
    • Shanxi
      • Xian、Shanxi、中国、710061
        • First Affiliated Hospital Of Medical College of Xian Jiaotong University
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • West China Hospital,Sichuan University
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • The First Affiliated Hospital, Zhejiang University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

male and female kidney transplantation patients with living-donor grafts, > 18 years of age

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
kidney transplantation patients with living-donor grafts

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
Graft survival, measured as the time between kidney transplant and the failure of the graft.
5-year
Recipient survival
大体时间:5-year
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.
5-year

次要结果测量

结果测量
大体时间
Average creatinine value
大体时间:5 years
5 years
The rate of acute rejection episodes
大体时间:5 years
5 years
The incidence of BPAR and its severity
大体时间:5 years
5 years
The incidence of NODM
大体时间:5 years
5 years
The incidence of infection
大体时间:5 years
5 years
The incidence of biopsy proven CNIs nephrotoxicity
大体时间:5 years
5 years
The rate of posttransplantation malignancies
大体时间:5 years
5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年4月1日

初级完成 (实际的)

2013年8月1日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2013年2月16日

首先提交符合 QC 标准的

2013年2月20日

首次发布 (估计)

2013年2月22日

研究记录更新

最后更新发布 (估计)

2014年6月18日

上次提交的符合 QC 标准的更新

2014年6月17日

最后验证

2014年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • COLO400ACN02

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