Accuracy of Glomerular Filtration Rate (GFR) Estimation Using Creatinine and Cystatin C and Albuminuria
eGFR-C
5 other identifiers
observational
1,249
1 country
6
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2014
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2014
CompletedFirst Submitted
Initial submission to the registry
April 15, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 29, 2021
September 1, 2021
5.8 years
April 15, 2015
September 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline
Study Arms (3)
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.
Eligibility Criteria
Adults with stage 3 CKD.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Derby Hospitals NHS Foundation Trust (Royal Derby Hospital)
Derby, Derbyshire, DE22 3NE, United Kingdom
King's College Hospital NHS Foundation Trust
London, Greater London, SE5 NRS, United Kingdom
Salford Royal NHS Foundation Trust (Salford Royal Hospital)
Salford, Greater Manchester, M6 8HD, United Kingdom
East Kent Hospitals NHS Trust (Kent & Canterbury Hospital)
Canterbury, Kent, CT1 3NG, United Kingdom
University Hospitals of Leicester NHS Trust (Leicester General Hospital)
Leicester, Leicestershire, LE54PW, United Kingdom
University Hospital Birmingham NHS Trust (Queen Elizabeth Hospital Birmingham)
Birmingham, West Midlands, B15 2TH, United Kingdom
Related Publications (2)
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.
PMID: 24423077BACKGROUNDRowe 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.
PMID: 31084924DERIVED
Related Links
Biospecimen
Serum/plasma and urine will be stored for potential analysis of future markers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edmund Lamb, PhD, FRCPath
East Kent Hospitals University NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2015
First Posted
May 4, 2015
Study Start
April 8, 2014
Primary Completion
January 31, 2020
Study Completion
December 31, 2021
Last Updated
September 29, 2021
Record last verified: 2021-09