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临床试验/NCT03605810
NCT03605810已完成不适用

An Estimated Glomerular Filtration Rate (eGFR) Level Prediction

Bayer1 个研究点 分布在 1 个国家目标入组 5,132,200 人开始时间: 2018年7月15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
Bayer
入组人数
5,132,200
试验地点
1
主要终点
Performance of classification to predict eGFR

研究概览

简要总结

Scientific analyses are frequently performed on e.g. health insurance databases to study the usage and effectiveness of drugs in real life.

Kidney function is known to have an influence on a patients disease development and/or drug levels in blood.

However, often direct measures for kidney function are not available in databases.

This study plans to develop tools to classify the renal function of patients, which helps scientists to identify patient cohorts (groups of patients sharing same characteristics) for scientific analyses.

详细描述

Renal impairment is a common comorbidity in patients with diverse main underlying diseases and a pathology accompanying increasing age. Renal function might be an important modifier of treatment effects.

Population-based administrative claims databases are increasingly used in large-scale comparative outcomes studies of drug treatments. However, claims databases often lack information on laboratory tests results limiting their usefulness in Real-World Evidence(RWE) research of patients with renal impairment.

There is a need to develop methods for identification of patients with renal dysfunction from healthcare administrative claims-based proxies.

The main objective of this study is the development of algorithms/models to predict eGFR values and/or classes for patients at certain time point based on entries in claims database (demographic characteristics, clinical diagnoses, procedures and drug treatments) for a general population and a variety of use-cases (atrial fibrillation, coronary artery disease, type 2 diabetes mellitus patients sub-populations). To achieve this, modern data-driven machine learning techniques will be applied to discover relationships between renal status, measured by eGFR, and longitudinal patient-level data.

Evaluation of models' performance (out of sample validation, benchmark test, performance differences between eGFR value prediction algorithms and classification models tailored for the pre-defined eGFR classes) will be done as well.

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Performance of classification to predict eGFR

时间窗: From eGRF values starting and lasting 180d + 370d

For numeric models cross-validated performance is measured as correlation via r\*2. Class based performances are measured as cross-validated sensitivities given pre-defined false discovery rates with following definition for positives and negatives: Observed eGFR class X: * positive: eGFR measured at begin of time frame is in class X * negative: eGFR measured at begin of time frame is not in class X Class predicted by model: * positive: eGFR predicted is class X * negative: eGFR predicted is not class X

次要结局

未报告次要终点

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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