Accuracy of Glomerular Filtration Rate (GFR) Estimation Using Creatinine and Cystatin C and Albuminuria (eGFR-C)

September 28, 2021 updated by: University of Birmingham

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).

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

1249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Derbyshire
      • Derby, Derbyshire, United Kingdom, DE22 3NE
        • Derby Hospitals NHS Foundation Trust (Royal Derby Hospital)
    • Greater London
      • London, Greater London, United Kingdom, SE5 NRS
        • King's College Hospital NHS Foundation Trust
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust (Salford Royal Hospital)
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • East Kent Hospitals NHS Trust (Kent & Canterbury Hospital)
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE54PW
        • University Hospitals of Leicester NHS Trust (Leicester General Hospital)
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • University Hospital Birmingham NHS Trust (Queen Elizabeth Hospital Birmingham)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with stage 3 CKD.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

East Kent Hospitals University NHS Foundation Trust
National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Edmund Lamb, PhD, FRCPath, East Kent Hospitals University NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2014

Primary Completion (Actual)

January 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_13-176
  • 15268 (UKCRN)
  • ISRCTN42955626 (Registry Identifier: ISRCTN)
  • 11/103/01 (Other Grant/Funding Number: NIHR HTA)
  • 13/LO/1349 (Other Identifier: NRES Committee: South East Coast - Surrey)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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