Use of Wearables to Detect Infections in Kidney Transplant Recipients (RENALERT)

April 9, 2024 updated by: Prof. Ondřej Viklický, M.D., Ph.D., Institute for Clinical and Experimental Medicine

Use of Continuous Biomonitoring for Detection of Infectious Complications in Kidney Transplant Recipients

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vojtech Petr, MD
  • Phone Number: 720-639-0909
  • Email: petv@ikem.cz

Study Locations

  • Czechia
      • Prague, Czechia, 14021
        • Institute for Clinical and Experimental Medicine
        • Contact:
        • Principal Investigator:
          • Ivan Zahradka, MD
        • Sub-Investigator:
          • Vojtech Petr, MD
        • Sub-Investigator:
          • Katarina Jakubov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients followed at the Institute for Clinical and Experimental Medicine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the algorithm at detecting infections at presymptomatic stage
Time Frame: The primary endpoint will be assessed periodically throughout the study, up to 24 months.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of in-patient admissions
Time Frame: Periodically throughout the study, up to 24 months.
Any hospital admission for infection treatment is considered an event of this outcome
Periodically throughout the study, up to 24 months.
Incidence of decrease/increase of Quality of Life
Time Frame: Periodically throughout the study, up to 24 months.
Score change of WHOQOL-BREF from baseline.
Periodically throughout the study, up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-24-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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