Accuracy of Glomerular Filtration Rate (GFR) Estimation Using Creatinine and Cystatin C and Albuminuria
NCT ID: NCT02433002
Last Updated: 2021-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1249 participants
OBSERVATIONAL
2014-04-08
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Sub-study of patterns of progression
A subset of the cohort (n=375) will receive annual reference GFR tests.
No interventions assigned to this group
Biological variability study
In a further sub-study 20 participants will undergo the reference test four times over four weeks.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or over
* Written informed consent
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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East Kent Hospitals University NHS Foundation Trust
OTHER_GOV
National Institute for Health Research, United Kingdom
OTHER_GOV
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Edmund Lamb, PhD, FRCPath
Role: PRINCIPAL_INVESTIGATOR
East Kent Hospitals University NHS Foundation Trust
Locations
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Derby Hospitals NHS Foundation Trust (Royal Derby Hospital)
Derby, Derbyshire, United Kingdom
King's College Hospital NHS Foundation Trust
London, Greater London, United Kingdom
Salford Royal NHS Foundation Trust (Salford Royal Hospital)
Salford, Greater Manchester, United Kingdom
East Kent Hospitals NHS Trust (Kent & Canterbury Hospital)
Canterbury, Kent, United Kingdom
University Hospitals of Leicester NHS Trust (Leicester General Hospital)
Leicester, Leicestershire, United Kingdom
University Hospital Birmingham NHS Trust (Queen Elizabeth Hospital Birmingham)
Birmingham, West Midlands, United Kingdom
Countries
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References
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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.
Rowe 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.
Related Links
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Plain English summary
Study website
Other Identifiers
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ISRCTN42955626
Identifier Type: REGISTRY
Identifier Source: secondary_id
11/103/01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
15268
Identifier Type: OTHER
Identifier Source: secondary_id
13/LO/1349
Identifier Type: OTHER
Identifier Source: secondary_id
RG_13-176
Identifier Type: -
Identifier Source: org_study_id
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