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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06364618
Other study ID # G-24-07
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2024
Est. completion date December 2027

Study information

Verified date April 2024
Source Institute for Clinical and Experimental Medicine
Contact Vojtech Petr, MD
Phone 720-639-0909
Email petv@ikem.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies. The main questions it aims to answer are: 1. What are the biometric data pattern changes in impending infections? 2. What accuracy the machine learning algorithm can achieve? Participants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - kidney transplant recipient - age 18 years or more - kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2) Exclusion Criteria: - recipient of another transplanted organ - terminal failure of another organ (heart, liver, lung) - diabetes mellitus type 1 - pregnant or breastfeeding woman - refusal to give informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Czechia Institute for Clinical and Experimental Medicine Prague

Sponsors (1)

Lead Sponsor Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Other Rate of in-patient admissions Any hospital admission for infection treatment is considered an event of this outcome Periodically throughout the study, up to 24 months.
Other Incidence of decrease/increase of Quality of Life Score change of WHOQOL-BREF from baseline. Periodically throughout the study, up to 24 months.
Primary Accuracy of the algorithm at detecting infections at presymptomatic stage Accuracy, sensitivity, specificity, negative and positive predictive value of the machine learning algorithm at detecting infections in presymptomatic stage in kidney transplant recipients. The primary endpoint will be assessed periodically throughout the study, up to 24 months.
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