Effect of Fenofibrate on Kidney Function: A 6-Week Randomized Crossover Trial in Healthy People
Abstract
Background Fenofibrate was associated with increases in serum creatinine concentrations. The effect of short-term fenofibrate treatment on kidney function was investigated in subjects with normal kidney function. Study design Double-blind, crossover, placebo-controlled. Setting and participants 24 middle-aged subjects with normal kidney function (estimated creatinine clearance > or = 80 mL/min). Intervention Subjects were treated with fenofibrate (160-mg/d tablet) and placebo in two 6-week periods separated by a washout. Outcomes and measurements The primary outcome measure was glomerular filtration rate measured by means of inulin clearance, with a test of noninferiority to rule out a change in the 95% confidence interval (CI) greater than 20%. Secondary outcomes included effective renal plasma flow measured by means of para-aminohippurate (PAH) clearance, creatinine clearance, creatinine secretion (ratio of creatinine to inulin clearance), serum cystatin C and uric acid, and urinary excretion of creatinine. Glomerular and tubular damage was evaluated by using albumin and retinol-binding protein levels and N-acetyl-beta-d-glucosaminidase activity. Results Inulin clearance was unchanged after fenofibrate (change [Delta] between treatments on 6-week values, 0.8 mL/min; 95% CI, -10.5 to 12.2; P = 0.9), but PAH clearance decreased (Delta, -33; 95% CI, -66 to -1; P = 0.05). Changes in inulin and PAH clearances were not greater than 20%. Plasma creatinine level increased (Delta, 0…
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The use of fibrates in patients with kidney disease has been limited due to safety concerns related to documented increases in serum creatinine.
“the use of fibrates in patients with kidney disease has been limited due to safety concerns related to the documented increases in serum creatinine (43,44)”
From Effects of Fibrates in Kidney Disease (2012) · cites this paper as [43]
Fenofibrate causes an initial plasma creatinine rise.
“an initial, well-recognised plasma creatinine rise [16]”
The initial plasma creatinine rise associated with fenofibrate appears to be partly due to a decrease in creatinine clearance without reduced inulin-derived GFR.
“The rise appears to be partly due to a decrease in creatinine clearance [16,21] without reduced inulinderived GFR [16,24]”
Serum cystatin C modestly increases in patients on fenofibrate without any change in inulin clearance and reverts shortly after drug withdrawal.
“Serum cystatin C, an indicator of renal dysfunction in type 2 diabetes, also modestly increases in patients on fenofibrate without any change in inulin clearance [16] and reverts shortly after drug withdrawal (J.-C.Ansquer, Laboratoires Fournier SA, Dijon, France, personal communication), but has not yet been measured in FIELD.”
The two studies had contrasting fenofibrate effects on renal plasma flow but both concluded there was no loss of glomerular function.
“Fenofibrate effects on renal plasma flow in these two studies were also contrasting [16,25], but both concluded there was no loss of glomerular function.”
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References 33 · Cited by 107
- Authors
- Ansquer, J.-C., Dalton, R. N., Caussé, E., Crimet, D., Le Malicot, K., & Foucher, C.
- Affiliations
- St Thomas' Hospital (GB)
- Centre Hospitalier Universitaire de Toulouse (FR)
- Corresponding author
- Foucher, Christelle
- Venue
- American Journal of Kidney Diseases
- Publisher
- Elsevier BV
- Published
- 2008-06
- Volume
- 51
- Issue
- 6
- Pages
- 904-913
- ISSN
- 0272-6386 (ISSN-L)
- OpenAlex
- W1978960952
- Cited by
- 107
- References
- 33
- Citations by year
- 2026: 7 · 2025: 6 · 2024: 3 · 2023: 3 · 2022: 5 · 2021: 3 · 2020: 6 · 2018: 4 · 2017: 6 · 2016: 2 · 2015: 4 · 2014: 8 · 2013: 4 · 2012: 16
- FWCI
- 8.04
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Kidney Diseases (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- fenofibrate, renal function, glomerular filtration rate, renal plasma flow, creatinine clearance, serum creatinine, inulin clearance, para-aminohippurate clearance, cystatin C, uric acid, tubular damage, drug-induced nephrotoxicity, non-inferiority, healthy volunteers, albuminuria
- MeSH terms
- Adult, Hypolipidemic Agents, Double-Blind Method, Female, Humans, Kidney, Male, Middle Aged, Fenofibrate, Cross-Over Studies
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