NCT03303222

Brief Summary

Measure trimethylamine oxide in the breath.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
3.4 years until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2.8 years

First QC Date

October 2, 2017

Last Update Submit

November 3, 2020

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • measurement of breath TMAO

    measurement of breath TMAO by breath analyser

    3 years

Study Arms (2)

patients on dialysis

patients with kidney disease treated by dialysis

Diagnostic Test: breath

patients with chronic kidney disease

patients with chronic kidney disease not treated by dialysis

Diagnostic Test: breath

Interventions

breathDIAGNOSTIC_TEST

measurement of volatile compounds, such as TMAO in exhaled breath and blood

Also known as: blood sample
patients on dialysispatients with chronic kidney disease

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with kidney disease under the care of Royal Free Hospital

You may qualify if:

  • patients with kidney disease under the care of Royal Free Hospital

You may not qualify if:

  • patients unable to provide informed consent
  • patients unable to exhale into breath analyser

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • andrew davenport, md

    UCL, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

andrew davenport, md

CONTACT

442077940500andrewdavenport@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

February 10, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Data will be filed in UCL library as PhD submission