Chronic Kidney Diseases Clinical Trial
— eGFR-COfficial 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
Verified date | September 2021 |
Source | University of Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Active, not recruiting |
Enrollment | 1249 |
Est. completion date | December 31, 2021 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Birmingham NHS Trust (Queen Elizabeth Hospital Birmingham) | Birmingham | West Midlands |
United Kingdom | East Kent Hospitals NHS Trust (Kent & Canterbury Hospital) | Canterbury | Kent |
United Kingdom | Derby Hospitals NHS Foundation Trust (Royal Derby Hospital) | Derby | Derbyshire |
United Kingdom | University Hospitals of Leicester NHS Trust (Leicester General Hospital) | Leicester | Leicestershire |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham | East Kent Hospitals University NHS Foundation Trust, National Institute for Health Research, United Kingdom |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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