Cystatin C as renal marker in patients receiving fenofibrate
Research type
Research Study
Full title
Role of cystatin C in the evaluation of renal function in patients receiving fenofibrate treatment for dyslipidaemia.
IRAS ID
150171
Contact name
Ivo Sama FOMBON
Contact email
Sponsor organisation
Queen's Hospital
Research summary
Increased serum creatinine is a major limitation to the use of fenofibrate in managing dyslipidaemia. The mechanism of the reversible increase in serum creatinine witnessed during treatment with fenofibrate is not fully understood, and whether the increase in creatinine is associated with kidney impairment remains debatable. Routine monitoring of kidney function is recommended for patients receiving fenofibrate treatment. However, limitations of the routinely used creatinine measurement for estimating glomerular filtration rate (GFR) are well documented. Also, the controversial increase in serum creatinine following treatment with fenofibrate casts further doubts on the use of creatinine for evaluating kidney function in patients receiving fenofibrate. Recent studies suggest cystatin C, is a better marker than creatinine for diagnosing kidney disease. This study will examine the effect of fenofibrate on kidney function and investigate whether cystatin C is a better marker than creatinine for evaluating kidney function in patients receiving fenofibrate treatment for dyslipidaemia.
The study will be conducted between September 2014 and December 2017 at laboratories at the Queen's Hospital Burton-on-Trent, Musgrove Park Hospital (MPH), Taunton and Hub Laboratory at Lisieux Way, Taunton. Study participants will include patients diagnosed with dyslipidaemia who will require treatment with fenofibrate. Fasting blood and spot urine samples will be collected before the participant starts treatment (baseline) and at three months, six months and 12 months after starting treatment. Kidney function will be tested using blood levels of creatinine, urea, cystatin C, neutrophil gelatinase-associated lipocalin (NGAL), and urine albumin/protein-to-creatinine ratio. Results obtained at the different stages of treatment will be compared to the baseline. Estimated GFR obtained using creatinine-based formulas will be compared to those of cystatin C-based equations. In vitro cellular studies will be carried out at the University of the West of England to examine the effect of fenofibrate on kidney cell line models.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
14/SW/1104
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion