Kidney DiseasesNCT03303222
Study to Develop a Breath Analyser to Detect Chronic Kidney Disease
An observational study of Kidney Diseases, run by University College, London.
Trial summary
Measure trimethylamine oxide in the breath. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- breath
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with kidney disease under the care of Royal Free Hospital
Who may be able to join
- patients with kidney disease under the care of Royal Free Hospital
Who cannot join
- patients unable to provide informed consent
- patients unable to exhale into breath analyser
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study to Develop a Breath Analyser to Detect Chronic Kidney Disease
Measure trimethylamine oxide in the breath.
Read the detailed description
Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients with kidney disease, and volatile compounds such as TMAO can be detected in the breath.
The investigators wish to develop a breath analyser to measure volatile compounds, such as TMAO in the breath in patients with kidney disease.
- Conditions
- Kidney Diseases
- Being tested
- breath
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathDiagnostic test
Also called blood sample
measurement of volatile compounds, such as TMAO in exhaled breath and blood
| Study group | Role | What they receive |
|---|---|---|
| patients on dialysis | patients with kidney disease treated by dialysis Receives: Diagnostic Test: breath | |
| patients with chronic kidney disease | patients with chronic kidney disease not treated by dialysis Receives: Diagnostic Test: breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of breath TMAO
measurement of breath TMAO by breath analyser
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start10 Feb 2021 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- andrew davenport, md, Principal investigator, UCL, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303222
- Sponsor's protocol ID
- IRAS 228416
- Status last verified
- Nov 2020
- First submitted
- 2 Oct 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be filed in UCL library as PhD submission
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Develop a Breath Analyser to Detect Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03303222
- Acronym / sponsor ID
- IRAS 228416
- Conditions
- Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 10 Feb 2021 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 5 Oct 2017 (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.
Measure trimethylamine oxide in the breath.
Detailed description
Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients with kidney disease, and volatile compounds such as TMAO can be detected in the breath.
The investigators wish to develop a breath analyser to measure volatile compounds, such as TMAO in the breath in patients with kidney disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients on dialysis | – | Diagnostic Test: breathpatients with kidney disease treated by dialysis |
| patients with chronic kidney disease | – | Diagnostic Test: breathpatients with chronic kidney disease not treated by dialysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with kidney disease under the care of Royal Free Hospital
Key inclusion criteria (1 listed)
- patients with kidney disease under the care of Royal Free Hospital
Key exclusion criteria (2 listed)
- patients unable to provide informed consent
- patients unable to exhale into breath analyser
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breathAlso: blood samplemeasurement of volatile compounds, such as TMAO in exhaled breath and blood | Diagnostic test | patients on dialysis, patients with chronic kidney disease |
Primary outcome
measurement of breath TMAO
Time frame: 3 years
measurement of breath TMAO by breath analyser
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No. Data will be filed in UCL library as PhD submission
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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. This study is not recruiting at the moment.
andrew davenport, md principal investigator
UCL, London
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases, run by University College, London.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact andrew davenport, md (442077940500, andrewdavenport@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of breath TMAO (time frame: 3 years). 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 4 Nov 2020.