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临床试验/NCT04258891
NCT04258891已完成不适用

Development and Validation of a Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

Paris Translational Research Center for Organ Transplantation18 个研究点 分布在 7 个国家目标入组 14,000 人开始时间: 2004年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14,000
试验地点
18
主要终点
Allograft survival probability

研究概览

简要总结

The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up.

As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.

详细描述

850 million individuals suffer from chronic kidney disease (CKD), while diabetes, cancer, and HIV/AIDS affect 422, 42, and 37 million individuals, respectively. End stage renal disease (ESRD) hence places a heavy burden on health systems worldwide. Linked to that, the kidney-disease-associated mortality rate worldwide has risen over the past decade, now causing the death of 5 to 10 million individuals every year.

In kidney transplantation, numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, sometimes leading to graft failure. Current approaches for investigating the relationship between these factors and graft failure have been limited by standard statistical approaches and by registries with an overall lack on granular data, including infrequent kidney function measurements for a single patient and convenience clinical samples. Identifying the determinants of graft failure with a dynamic approach may bring an original perspective to the traditional graft survival risk prediction model that are impeded by their reliance on low-granularity datasets, cross-sectional parameters, and limited follow-up.

研究设计

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

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

  • Kidney recipients transplanted after 2004
  • Kidney recipients over 18 years of age
  • Kidney recipients with at least two estimated glomerular filtration rate and proteinuria measurements after transplantation

排除标准

  • Combined transplantation

结局指标

主要结局

Allograft survival probability

时间窗: Up to 10 years after kidney transplantation

Allograft survival probability, calculated from a dynamic prediction system, based on clinical, histological, immunological and estimated glomerular filtration rate and proteinuria repeated measurements, assessed at the time of risk evaluation and that can be updated thereafter.

次要结局

  • Added prognostic value(Up to 10 years after kidney transplantation)

研究者

发起方
Paris Translational Research Center for Organ Transplantation
申办方类型
Other
责任方
Sponsor

研究点 (18)

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