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临床试验/NCT03474003
NCT03474003已完成不适用

Multicenter International Observational Study to Build and Validate Multidimensional Risk Score in the Clinical Setting of Kidney Allograft Biopsies to Predict Long-term Allograft Survival

Paris Translational Research Center for Organ Transplantation10 个研究点 分布在 3 个国家目标入组 7,557 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7,557
试验地点
10
主要终点
Allograft survival probability

研究概览

简要总结

To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, clinical trials and clinical decision-making.

Despite a clear pressing need, no population-scale prognostication system exists that will combine traditional factors and biomarker candidates to represent the complete spectrum of risk predicting parameters. To adequately predict transplant patients' individual risks of allograft loss, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, allograft precision phenotypes, ethnicity, immunosuppressive regimen monitoring, allograft infections, acute kidney injuries, and recipient immune profiles.

This project aims:

  1. To develop a generalizable, transportable, mechanistically and data driven composite surrogate end point in kidney transplantation;
  2. To validate several risk scores to predict kidney allograft survival and response to treatment of individual patients;

Eventually, it will provide an easily accessible tool to calculate individual patients' risk profiles after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.

详细描述

Background The field of kidney transplantation currently lacks robust models to predict long-term allograft failure, which represents a major unmet need in clinical care and clinical trials. This study aims to generate and validate an accessible scoring system that predicts individual patients' risk of long-term kidney allograft failure.

Main Outcome(s) and Measure(s)

A score based on classical statistical approaches to model determinants of allograft and patient survival (Cox model, multinomial regression). These models will be further completed with statistical approaches derived from artificial intelligence and machine learning.

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 recipient transplanted after 2002
  • Kidney recipient over 18 years of age

排除标准

  • Combined transplantation

结局指标

主要结局

Allograft survival probability

时间窗: Allograft survival probability at 7 year post transplantation

Allograft survival probability, calculated from a composite score (based on clinical, histological, immunological, and functional variables) assessed at the time of biopsy.

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
Principal Investigator
主要研究者

Professor Alexandre Loupy

Professor Alexandre Loupy

Paris Translational Research Center for Organ Transplantation

研究点 (10)

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