Kidney function assessment with finger-prick blood tests in different people and different settings
| ISRCTN | ISRCTN31697115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31697115 |
| IRAS number | 263206 |
| Secondary identifying numbers | CPMS 45543, IRAS 263206 |
- Submission date
- 04/08/2020
- Registration date
- 09/09/2020
- Last edited
- 19/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
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 June 2025
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
Contact information
Scientific
Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom
| Phone | +44 (0)2078480431 |
|---|---|
| kate.bramham@kcl.ac.uk |
Study information
| Study design | Observational cross-sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Renal function Assessment with Point of care creatinine testing In Diverse populations (RAPID) |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 05/05/2020 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 415; UK Sample Size: 415 |
| 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 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 | 30/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE5 9RS
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Sponsor information
University/education
The Strand
London
WC2R 2LS
England
United Kingdom
| Phone | +44 (0)2078483224 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Research organisation
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- BRS
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| 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 plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. The data is being stored on a research-specific database which is GDPR compliant (REDCap). It is also being stored on EDGE. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 8.0 | 29/10/2024 | 19/11/2024 | No | No |
Additional files
Editorial Notes
19/11/2024: The following changes were made to the study record:
1. Protocol uploaded.
2. The recruitment end date was changed from 30/11/2024 to 30/05/2025.
3. The overall study end date was changed from 31/12/2024 to 30/06/2025.
4. The intention to publish date was changed from 01/04/2025 to 01/09/2025.
5. IPD sharing plan added.
17/10/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2023 to 30/11/2024.
2. The overall end date was changed from 30/11/2023 to 31/12/2024.
3. The intention to publish date was changed from 01/03/2024 to 01/04/2025.
4. The plain English summary was updated to reflect these changes.
19/06/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2023 to 31/10/2023.
2. The overall end date was changed from 31/07/2023 to 30/11/2023.
3. The intention to publish date was changed from 01/12/2023 to 01/03/2024.
4. The plain English summary was updated to reflect these changes.
15/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 30/06/2023.
2. The overall end date was changed from 30/01/2023 to 31/07/2023.
3. The intention to publish date was changed from 01/03/2023 to 01/12/2023.
4. The plain English summary was updated to reflect these changes.
18/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2022 to 31/12/2022.
2. The overall end date was changed from 30/09/2022 to 30/01/2023.
3. The intention to publish date was changed from 01/12/2022 to 01/03/2023.
4. The plain English summary was updated to reflect these changes.
18/10/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/10/2021 to 31/03/2022.
2. The overall end date was changed from 28/02/2022 to 30/09/2022.
3. The intention to publish date was changed from 01/04/2022 to 01/12/2022.
4. The plain English summary was updated to reflect these changes.
23/02/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2021 to 28/02/2022.
2. The recruitment end date was changed from 28/02/2021 to 30/10/2021.
3. The plain English summary was updated to reflect these changes.
04/08/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).
