NCT04714853

Brief Summary

. This is a prospective observational pilot study to analyse gastrointestinal tract bacterial populations in peritoneal dialysis and haemodialysis patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular haemodialysis and peritoneal dialysis treatments in a Royal Free Hospital kidney care centre.

Trial Health

43
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 Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

7.8 years

First QC Date

February 10, 2016

Last Update Submit

January 15, 2021

Conditions

Kidney Failure

Keywords

microbiomehaemodialysisperitoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • generation of bacterial phylogenetic trees by identifying different bacteria from stool samples and oral swabs by analysis of bacterial ribosomal 16S

    observational

    5 years

Secondary Outcomes (1)

  • measure indoxyl sulphate (IS) and p-Cresyl sulfate (PCS) umol/L

    8 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 dialysis patients

You may qualify if:

  • Patients age 18 years and older up to 80 years
  • Under the care of the Royal Free Hospital with chronic kidney disease and established on regular haemodialysis or peritoneal dialysis.
  • Able to provide written informed consent obtained

You may not qualify if:

  • Patients unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital

London, NW32QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • andrew davenport

    UCL Centre for Nephrology, Royal Free Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

vashist deelchand

CONTACT

02077940500vashist.deelchand@nhs.net

ruth yang

CONTACT

02077940500ruth.yang@nhs.net

Study Design

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

Study Record Dates

First Submitted

February 10, 2016

First Posted

January 19, 2021

Study Start

October 1, 2015

Primary Completion

August 1, 2023

Study Completion

December 1, 2024

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

GB(1)