Kidney Transplant InfectionRENALERTNCT06364618
Use of Wearables to Detect Infections in Kidney Transplant Recipients
An observational study of Kidney Transplant Infection, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients followed at the Institute for Clinical and Experimental Medicine.
Who may be able to join
- kidney transplant recipient
- age 18 years or more
- kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Institute for Clinical and Experimental Medicine
Prague, 14021
Tereza Metelcova, PhD, +420261262125, tereza.metelcova@ikem.cz
Ivan Zahradka, MD
About this study
Official title: 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:
- What are the biometric data pattern changes in impending infections?
- 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.
- Conditions
- Kidney Transplant Infection
- Keywords
- biometric data, continuous monitoring, machine learning, early alert system, infection, kidney transplantation
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary endpoint will be assessed periodically throughout the study, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ondřej Viklický, M.D., Ph.D., Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364618
- Sponsor's protocol ID
- G-24-07
- Acronym
- RENALERT
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Continuous Biomonitoring for Detection of Infectious Complications in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06364618
- Acronym / sponsor ID
- RENALERT / G-24-07
- Conditions
- Kidney Transplant Infection
- Keywords
- biometric data, continuous monitoring, machine learning, early alert system, infection, kidney transplantation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the biometric data pattern changes in impending infections?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients followed at the Institute for Clinical and Experimental Medicine.
Key inclusion criteria (3 listed)
- kidney transplant recipient
- age 18 years or more
- kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
Related trials for Kidney Transplant Infection
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
RecruitingPhase 1/2
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Infection, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vojtech Petr, MD (720-639-0909, petv@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.