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, email@example.com
Dr Kate Bramham, firstname.lastname@example.org
Dr Kate Bramham
Weston Education Centre
10 Cutcombe Road
CPMS 45543, IRAS 263206
Renal function Assessment with Point of care creatinine testing In Diverse populations (RAPID)
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
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; email@example.com), ref: 20/LO/0620
Primary study design
Secondary study design
Cross sectional study
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
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).
Primary outcome measure
Measured at a single time point:
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
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
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
Overall trial end date
Reason abandoned (if study stopped)
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)
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
Recruitment end date
Countries of recruitment
Trial participating centre
King's College Hospital
Trial participating centre
The Royal London Hospital
Whitechapel Road Whitechapel
British Renal Society
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
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
Participant level data
To be made available at a later date
Basic results (scientific)