Chronic Kidney DiseaseseGFR-CNCT02433002
Accuracy of Glomerular Filtration Rate (GFR) Estimation Using Creatinine and Cystatin C and Albuminuria
An observational study of Chronic Kidney Diseases, run by University of Birmingham at 6 sites in United Kingdom.
Trial summary
The eGFR-C study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 1,249 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 8 Apr 2014to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with stage 3 CKD.
Who may be able to join
- Patients with stage 3 CKD (GFR 30-59 mL/min/1.73 m2) as defined internationally, diagnosed using MDRD/CKDEPI eGFR (at least two consecutive test results in this range at least 90 days apart, with the most recent test in the last 12 months)
- Aged 18 years or over
- Written informed consent
Who cannot join
- History of untoward reactions to iodinated contrast media or allergy to topical iodine
- Episode of acute kidney injury in previous 6 months (as defined by the Acute Kidney Injury Network criteria)
- Amputation of whole or part-limb
- Pregnant or breastfeeding
- Known current alcohol or drug abuse
- Kidney transplant recipient
Show all 9Show fewer
- Any condition with an expected survival of less than study duration
- Inability to comply with study schedule and follow-up
- Inability to provide informed consent e.g. due to cognitive impairment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
University Hospital Birmingham NHS Trust (Queen Elizabeth Hospital Birmingham)
Birmingham, West Midlands, B15 2TH
East Kent Hospitals NHS Trust (Kent & Canterbury Hospital)
Canterbury, Kent, CT1 3NG
Derby Hospitals NHS Foundation Trust (Royal Derby Hospital)
Derby, Derbyshire, DE22 3NE
University Hospitals of Leicester NHS Trust (Leicester General Hospital)
Leicester, Leicestershire, LE54PW
King's College Hospital NHS Foundation Trust
London, Greater London, SE5 NRS
Salford Royal NHS Foundation Trust (Salford Royal Hospital)
Salford, Greater Manchester, M6 8HD
About this study
Official title: Accuracy of Glomerular Filtration Rate Estimation Using Creatinine & Cystatin C & Albuminuria for Monitoring Disease Progression in Patients With Stage 3 Chronic Kidney Disease: Prospective Longitudinal Study in a Multi-ethnic Population
The eGFR-C study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) chronic kidney disease (CKD).
Read the detailed description
The eGFR-C study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) CKD. Participants will be recruited from hospital clinics and General Practitioner (GP) practices at six major United Kingdom (UK) centres.
The best measure of kidney function is accepted to be the glomerular filtration rate (GFR), which measures the ability of the kidney to filter blood and is widely used in clinical practice. A low GFR suggests poor kidney function. An estimate of GFR can be obtained from a simple blood test.
Participants will undergo reference GFR testing at study entry with a second follow-up reference test three years later. The reference test involves injecting a small amount of iohexol into a vein and taking blood samples over the next 4 hours to see how quickly the iohexol disappears from the blood stream as a result of glomerular filtration. The rate at which iohexol disappears is equivalent to the level of kidney function. Blood tests for monitoring kidney function, including testing for creatinine and cystatin C, and measurement of urinary albumin will be done every six months during the study period.
Iohexol measured GFR will be accepted as the reference ('gold standard') measure of kidney function against which each GFR-estimating equations will be compared. The alternative estimated measures of GFR, derived from measuring substances (creatinine and cystatin C) in the blood, will be compared against the reference test. An important outcome is how much the reference test changes over the three years of the study, and how well the surrogate measures reflect this change.
The investigators will also collect accurate test cost data for subsequent cost-effectiveness analysis (e.g. do the relative costs of the tests justify any change in practice due to improved performance of one test compared to another?).
- Conditions
- Chronic Kidney Diseases
- Keywords
- eGFR, CKD, Cystatin, Creatinine, Albuminuria
- Medical subject headings
- Renal Insufficiency, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Main study | 1300 participants will undergo baseline (month 0) and final (month 36) reference GFR, estimated GFR (eGFR) and urinary albumin-to-creatinine ratio (ACR) tests. Additionally they will provide ACR and eGFR tests at 6-monthly intervals. | |
| Sub-study of patterns of progression | A subset of the cohort (n=375) will receive annual reference GFR tests. | |
| Biological variability study | In a further sub-study 20 participants will undergo the reference test four times over four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of estimated Glomerular Filtration Rate values within 30% of 'true' Glomerular Filtration Rate
The accuracy of Glomerular Filtration Rate (GFR) estimating equations is commonly expressed as the P30 value, the percentage of estimated GFR values within 30% of 'true' GFR.
The eGFR-C study will estimate and compare the accuracy and precision of GFR-estimating equations based on the Modification of Diet in Renal Disease (MDRD) equation and three Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations using either creatinine or cystatin C or a combination of both in people with stage 3 Chronic Kidney Disease (CKD), expressed as the P30 value.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study start8 Apr 2014
- Primary completion31 Jan 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- East Kent Hospitals University NHS Foundation Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Edmund Lamb, PhD, FRCPath, Principal investigator, East Kent Hospitals University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433002
- Sponsor's protocol ID
- RG_13-176
- Other IDs
- ISRCTN42955626, 11/103/01, 15268, 13/LO/1349
- Acronym
- eGFR-C
- Status last verified
- Sep 2021
- First submitted
- 15 Apr 2015
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Lamb EJ, Brettell EA, Cockwell P, Dalton N, Deeks JJ, Harris K, Higgins T, Kalra PA, Khunti K, Loud F, Ottridge RS, Sharpe CC, Sitch AJ, Stevens PE, Sutton AJ, Taal MW; eGFR-C study group. The eGFR-C study: accuracy of glomerular filtration rate (GFR) estimation using creatinine and cystatin C and albuminuria for monitoring disease progression in patients with stage 3 chronic kidney disease--prospective longitudinal study in a multiethnic population. BMC Nephrol. 2014 Jan 14;15:13. doi: 10.1186/1471-2369-15-13.
PubMed 24423077Rowe C, Sitch AJ, Barratt J, Brettell EA, Cockwell P, Dalton RN, Deeks JJ, Eaglestone G, Pellatt-Higgins T, Kalra PA, Khunti K, Loud FC, Morris FS, Ottridge RS, Stevens PE, Sharpe CC, Sutton AJ, Taal MW, Lamb EJ; eGFR-C Study Group. Biological variation of measured and estimated glomerular filtration rate in patients with chronic kidney disease. Kidney Int. 2019 Aug;96(2):429-435. doi: 10.1016/j.kint.2019.02.021. Epub 2019 Mar 7.
PubMed 31084924
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Glomerular Filtration Rate Estimation Using Creatinine & Cystatin C & Albuminuria for Monitoring Disease Progression in Patients With Stage 3 Chronic Kidney Disease: Prospective Longitudinal Study in a Multi-ethnic Population
- ClinicalTrials.gov ID
- NCT02433002
- Acronym / sponsor ID
- eGFR-C / RG_13-176
- Conditions
- Chronic Kidney Diseases
- Keywords
- eGFR, CKD, Cystatin, Creatinine, Albuminuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,249 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- East Kent Hospitals University NHS Foundation Trust, National Institute for Health Research, United Kingdom
- Study start
- 8 Apr 2014 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The eGFR-C study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) chronic kidney disease (CKD).
Detailed description
The eGFR-C study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) CKD. Participants will be recruited from hospital clinics and General Practitioner (GP) practices at six major United Kingdom (UK) centres.
The best measure of kidney function is accepted to be the glomerular filtration rate (GFR), which measures the ability of the kidney to filter blood and is widely used in clinical practice. A low GFR suggests poor kidney function. An estimate of GFR can be obtained from a simple blood test.
Participants will undergo reference GFR testing at study entry with a second follow-up reference test three years later. The reference test involves injecting a small amount of iohexol into a vein and taking blood samples over the next 4 hours to see how quickly the iohexol disappears from the blood stream as a result of glomerular filtration. The rate at which iohexol disappears is equivalent to the level of kidney function. Blood tests for monitoring kidney function, including testing for creatinine and cystatin C, and measurement of urinary albumin will be done every six months during the study period.
Iohexol measured GFR will be accepted as the reference ('gold standard') measure of kidney function against which each GFR-estimating equations will be compared. The alternative estimated measures of GFR, derived from measuring substances (creatinine and cystatin C) in the blood, will be compared against the reference test. An important outcome is how much the reference test changes over the three years of the study, and how well the surrogate measures reflect this change.
The investigators will also collect accurate test cost data for subsequent cost-effectiveness analysis (e.g. do the relative costs of the tests justify any change in practice due to improved performance of one test compared to another?).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Main study | – | –1300 participants will undergo baseline (month 0) and final (month 36) reference GFR, estimated GFR (eGFR) and urinary albumin-to-creatinine ratio (ACR) tests. Additionally they will provide ACR and eGFR tests at 6-monthly intervals. |
| Sub-study of patterns of progression | – | –A subset of the cohort (n=375) will receive annual reference GFR tests. |
| Biological variability study | – | –In a further sub-study 20 participants will undergo the reference test four times over four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with stage 3 CKD.
Key inclusion criteria (3 listed)
- Patients with stage 3 CKD (GFR 30-59 mL/min/1.73 m2) as defined internationally, diagnosed using MDRD/CKDEPI eGFR (at least two consecutive test results in this range at least 90 days apart, with the most recent test in the last 12 months)
- Aged 18 years or over
- Written informed consent
Key exclusion criteria (9 listed)
- History of untoward reactions to iodinated contrast media or allergy to topical iodine
- Episode of acute kidney injury in previous 6 months (as defined by the Acute Kidney Injury Network criteria)
- Amputation of whole or part-limb
- Pregnant or breastfeeding
- Known current alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of estimated Glomerular Filtration Rate values within 30% of 'true' Glomerular Filtration Rate
Time frame: Baseline
The accuracy of Glomerular Filtration Rate (GFR) estimating equations is commonly expressed as the P30 value, the percentage of estimated GFR values within 30% of 'true' GFR. The eGFR-C study will estimate and compare the accuracy and precision of GFR-estimating equations based on the Modification of Diet in Renal Disease (MDRD) equation and three Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations using either creatinine or cystatin C or a combination of both in people with stage 3 Chronic Kidney Disease (CKD), expressed as the P30 value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 24423077Lamb EJ, Brettell EA, Cockwell P, Dalton N, Deeks JJ, Harris K, Higgins T, Kalra PA, Khunti K, Loud F, Ottridge RS, Sharpe CC, Sitch AJ, Stevens PE, Sutton AJ, Taal MW; eGFR-C study group. The eGFR-C study: accuracy of glomerular filtration rate (GFR) estimation using creatinine and cystatin C and albuminuria for monitoring disease progression in patients with stage 3 chronic kidney disease--prospective longitudinal study in a multiethnic population. BMC Nephrol. 2014 Jan 14;15:13. doi: 10.1186/1471-2369-15-13.
- Derived from this study: PubMed 31084924Rowe C, Sitch AJ, Barratt J, Brettell EA, Cockwell P, Dalton RN, Deeks JJ, Eaglestone G, Pellatt-Higgins T, Kalra PA, Khunti K, Loud FC, Morris FS, Ottridge RS, Stevens PE, Sharpe CC, Sutton AJ, Taal MW, Lamb EJ; eGFR-C Study Group. Biological variation of measured and estimated glomerular filtration rate in patients with chronic kidney disease. Kidney Int. 2019 Aug;96(2):429-435. doi: 10.1016/j.kint.2019.02.021. Epub 2019 Mar 7.
- Study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund Lamb, PhD, FRCPath principal investigator
East Kent Hospitals University NHS Foundation Trust
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by University of Birmingham at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of estimated Glomerular Filtration Rate values within 30% of 'true' Glomerular Filtration Rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02433002, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.