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Frequency of renal monitoring - cystatin-C and creatinine study

To investigate whether baseline renal function measured by Cystatin-C (CY0) or baseline renal function measured by serum creatinine (SC0) better predicts future change in renal function over time (between 12 weeks and 24 months).

Background

Kidney function declines with age, which means the kidneys cannot filter waste products from the blood efficiently; increasing the risk of suffering or dying from heart attack or stroke.

Kidney function is tested by estimating the glomerular filtration rate (eGFR), a blood test that uses the waste product creatinine. Currently the testing frequency is based on expert opinion, not research evidence, and varies from person-to-person according to the extent of kidney function decline.

This study aims to assess the optimal frequency of testing, and investigate the use of another measurement, cystatin-c, as an alternative way of monitoring kidney function.

Patients will be recruited from general practices and invited to attend a research clinic in their usual surgery. With informed consent blood samples will be taken to measure creatinine, cystatin C, and lipid profiles. A urine sample will be collected to measure the albumin:creatinine ratio (ACR). These tests are indicators of kidney function. We shall collect demographic details (age, sex, ethnicity), medical information ( diabetes, chronic heart failure, blood pressure and surgical history). Current medications will be recorded. The health status instruments EQ5D-5L and ICECAP-A will be completed. Participants will be reviewed every 6 months for two years, when the blood and urine test will be repeated. Illnesses and medication changes during the intervals between appointments will be recorded. The EQ5D-5L and ICECAP will be completed 6 monthly.Participants will attend seven study visits; the base line visit will last approximately 45 minutes; subsequent visits will be between 15 and 30 minutes. Routine clinical measurements (BP, creatinine and urine tests) will be reported back the participant's GP.

This study is funded by the NHS via the National Institute for Health Research, a partnership between the University of Oxford and Oxford University Hospitals NHS Trust.

Study Design:  Multi-centre observational study
Sponsor University of Oxford
Chief Investigator: Professor Rafael Perera, University of Oxford
Funder: NIHR
Ethical Approval: 13/SC/0517