Condition category
Urological and Genital Diseases
Date applied
04/08/2020
Date assigned
09/09/2020
Last edited
09/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys don't work as well as they should. It's a common condition often associated with getting older. It can affect anyone, but it's more common in people who are black or of south Asian origin.
GFR stands for Glomerular Filtration Rate, which is a measure of how well the kidneys are working. A nuclear medicine GFR test gives an accurate measure of overall kidney function.
Point of care (POC) testing with finger-prick blood monitoring is now available to assess kidney function with the finger-prick method, giving results in less than a minute without the additional cost of venous blood-taking, transportation and processing. Rapid availability of POC-Cr results could provide instant information about kidney health for high-risk groups in the black and minority ethnic (BAME) community (e.g. in faith-based settings).
In order to harness the benefits of POC-Cr self-monitoring, it is important to understand and interpret intra-patient variability in capillary blood results, potentially without need for complete alignment with laboratory tests. Self-monitoring may introduce increased anxiety and requirement for additional interaction with health care services.
Our overall aim is to develop and pilot a UK community-based screening and CKD monitoring program to address health inequalities in CKD, focusing on people of BAME.

Who can participate?
Adults over 18 years, either undergoing formal nuclear medicine glomerular filtration rate testing or has chronic kidney disease or at risk of chronic kidney disease.

What does the study involve?
In the first part of the study, participants will provide a drop of blood to test kidney function. Other information will be gathered from the hospital database. Some participants will go on to the second part of the study which involves participants taking measurements of their own using a portable device (StatSensor®) four times a day for 10 days.

What are the possible benefits and risks of participating?
No immediate benefit but it will help to provide information that may improve the care of patients with kidney disease in the future.
There are no risks to taking part, other than minimal discomfort of the blood tests. The amount of extra blood that we take will not affect patients.

Where is the study run from?
King's College Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2020 to April 2021

Who is funding the study?
British Renal Society

Who is the main contact?
Danilo Nebres, d.nebres@nhs.net
Dr Kate Bramham, kate.bramham@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kate Bramham

ORCID ID

Contact details

Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom
+44 (0)2078480431
kate.bramham@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 45543, IRAS 263206

Study information

Scientific title

Renal function Assessment with Point of care creatinine testing In Diverse populations (RAPID)

Acronym

RAPID

Study hypothesis

1. Thresholds of point-of-care creatinine can be identified to be used for CKD diagnosis in people of different ethnicities
2. Serial home point-of-care creatinine by patients is accurate and feasible

Ethics approval

Approved 17/07/2020, London - Bromley Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8063; bromley.rec@hra.nhs.uk), ref: 20/LO/0620

Study design

Observational cross-sectional

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Renal failure

Intervention

This is a multi-centre cross-sectional and prospective longitudinal cohort study. Primary objectives include assessment of Point of Care Creatinine (POC-Cr) accuracy and precision in order to define thresholds for screening which identify individuals with Chronic Kidney Disease (CKD) (Study A) and exploration of variability and patient acceptability of self-monitoring of POC-Cr including Ease or Simplicity of Use (Study B).

375 participants (including at least 125 of African/African-Caribbean ancestry and 125 Asian background) having venous serum creatinine and 99mTc-DTPA nuclear medicine testing will be recruited to a cross sectional study (Study A).

40 patients with CKD or at risk of kidney disease will be recruited to a one week longitudinal study (Study B).

Study A: POC-Cr will be assessed on a drop of capillary whole blood by the research team and venous serum creatinine for routine care (Isotope Dilution Mass Spectrometry (IDMS) Traceable Enzymatic assay) and 99mTc-DTPA glomerular filtration rate testing will be extracted from hospital laboratory databases.

Study B: Participants will be trained to use the StatSensor® by the research team and time taken recorded. Participants will be taught how to perform quality controls, finger prick lancing and sample analysis. All sample results will be digitally recorded by the device and downloaded after the device is returned. Participants will be asked to self-monitor four times per day (first thing in morning, midday, before evening meal/early evening, before bed) and each test recorded in a paper diary or electronically as desired. Details reported will include time of test, test success, device and non-device failures (test results, missed testing and reasons for missed test (e.g. forgot, did not want to test) and adverse events (e.g. pain, infection, pre-syncopal or syncopal episode).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured at a single time point:
Study A:
1. Estimated glomerular filtration rate (eGFR) measured using Point of care – creatinine (POC-Cr)
2. Formal GFR assessment (Measured GFR (MGFR) and Venous Creatinine) measured using venous creatinine results from the laboratory and the MGFR results from the nuclear medicine department
Study B:
1. Test success rate, safety, training time, patient experience and acceptability of serial capillary POC-Cr testing measured on the final visit using SUTAQ questionnaire

Secondary outcome measures

Study B:
Measured during baseline and final visit:
1. Capillary creatinine measured using Point of care – creatinine (POC-Cr)
2. Venous serum enzymatic creatinine concentrations (serum Cr) measured using venous creatinine results from the laboratory

Overall trial start date

05/05/2020

Overall trial end date

30/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18 years of age or older
2. Willing to complete all study procedures
3. Patients undergoing formal nuclear medicine glomerular filtration rate testing (Study A only)
4. Has Chronic Kidney disease (CKD) KDIGO criteria or is at risk of CKD due to heart disease or diabetes as determined by physician (Study B only)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 415; UK Sample Size: 415

Participant exclusion criteria

1. Unable or unwilling to give informed consent
2. Any condition which would make finger prick contraindicated e.g. severe skin conditions, bleeding disorder
3. Study A: If formal GFR testing has been requested only because estimated GFR is not considered to reflect true GFR (e.g. liver disease)

Recruitment start date

21/07/2020

Recruitment end date

28/02/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

The Royal London Hospital
Whitechapel Road Whitechapel
London
E1 1BB
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

The Strand
London
WC2R 2LS
United Kingdom
+44 (0)2078483224
reza.razavi@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Research organisation

Funder name

British Renal Society

Alternative name(s)

BRS

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Conference presentation of study process and results at UK Kidney Week, American Society of Nephrology Conference or the European Renal Association conference and related Renal Conference.
Publication of results in a renal specific recognised impact journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/04/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/08/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).