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临床试验/NCT05229939
NCT05229939已完成不适用

Performances of Estimated Glomerular Filtration Rate Equations in Kidney Transplant Recipients

Paris Translational Research Center for Organ Transplantation10 个研究点 分布在 4 个国家目标入组 11,412 人开始时间: 2000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
11,412
试验地点
10
主要终点
Measured glomerular filtration rate (mGFR)

研究概览

简要总结

Accurate estimation of the glomerular filtration rate (GFR) is crucial for the management of kidney recipients, since it is the most predictive parameter of allograft failure that drives patient monitoring and decision-making. Standard and recent race-free GFR equations have been developed in native kidneys, but their performances in transplant kidney population remains unknown. We aimed at developing a kidney-transplant-specific GFR equation, and comparing its performance to standard GFR equations.

详细描述

Historically, GFR equations, which predict the measured GFR (mGFR), were developed on patients with native kidneys and were further validated and used in kidney recipients. However, studies have shown significant heterogeneity in the performances of GFR equations when applied in kidney recipients, which may be attributed to variations and intrinsic characteristics specific to the transplant population. We thus made the hypothesis that GFR equations developed on a large, well-phenotyped kidney recipient cohort might achieve good performances in predicting mGFR.

The project therefore aims to:

  1. Develop new kidney-recipient-specific (KRS) GFR equations and compare their performances with the standard GFR equations
  2. Investigate whether the use of race increasers the performances of the new kidney-recipient-specific (KRS) GFR equations
  3. Evaluate the effects of the new equations on the chronic kidney disease (CKD) prevalence and GFR stage

This study will provide us with data of kidney transplant patients that may allow the development of a new KRS GFR equation.

A new KRS GFR equation that presents with increased performances, as compared to current GFR equations, will improve the GFR calculation in kidney recipients, and therefore improve clinical decisions and the long-term kidney allograft management. Decisions regarding the return to dialysis or placement on the transplant waiting list will be taken with more accuracy and therefore potentially improve the financial allocation of kidney transplantation for the society.

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

  • Living or deceased donor kidney recipient transplanted between 01/01/2000 and 01/01/
  • Men or women over 18 years of age.
  • Written informed consent at the time of transplantation for the center database.

排除标准

  • Combined transplantation

结局指标

主要结局

Measured glomerular filtration rate (mGFR)

时间窗: Up to 15 years after kidney transplantation

Isotopic measurements of GFR

次要结局

未报告次要终点

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 (10)

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