Effect of Fenofibrate on Kidney Function: a Six-week Randomized Cross-over Trial in Healthy People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543647
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : January 19, 2015
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
The purpose of this study was to test the effect of fenofibrate treatment on glomerular filtration rate (GFR), kidney hemodynamics and tubular function in middle-aged subjects with normal kidney function to further investigate the increase in creatinine levels observed in fenofibrate-treated subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Fenofibrate 160 mg tablet Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Cross-over, Placebo-controlled Study Evaluating the Effect of Fenofibrate 160 mg Tablets on Glomerular Filtration Rate and Other Renal Function Test in Healthy Subjects
Study Start Date : August 2002
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Fenofibrate 160 mg tablet
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. Glomerular filtration rate (GFR) assessed by the measure of inulin clearance [ Time Frame: After two periods of 6 weeks treatment (fenofibrate and placebo in cross-over) separated by a 6wks wash out ]

Secondary Outcome Measures :
  1. GFR evaluated by raw values of plasma creatinine and cystatin C levels [ Time Frame: before and after each treatment period ]
  2. Renal haemodynamics evaluated by raw values of renal plasma and blood flows [ Time Frame: before and after each treatment period ]
  3. Tubular function: creatinine clearance, albuminuria, urine N-acetyl Beta D glucosaminidase and Retinol Binding Protein, sodium clearance and sodium fractional excretion [ Time Frame: before and after each treatment period ]
  4. Other functions : blood and urine urea, total proteins, albumin, uric acid, Na+, K+, blood fasting glucose, urinary creatinine, erythrocytes, leukocytes, casts and Calculated osmolarity, free water and urinary urate [ Time Frame: before and after each treatment period ]

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male and female
  • Age: 30-60 years old
  • Subjects with normal renal function as documented by: Plasma creatinine < 130 µmol/L, AND Cockcroft & Gault creatinine clearance (Co Cr CL) >80 ml/min
  • Certified as normal by a comprehensive medical assessment and laboratory investigations the results of which are within the normal range /or clinically acceptable for the present subjects and who have a negative urinary screen for drugs of abuse.
  • Written informed consent

Exclusion Criteria:

  • Body Mass Index (BMI) ≥ 30 kg/m² or <18 kg/m².
  • Pregnant, breast-feeding, or woman with child bearing potential without a reliable method of contraception.
  • Having received an investigational drug in the last 90 days before date of inclusion.
  • With known hypersensitivity to fibrates.
  • Unable or unwilling to comply with the protocol, or likely to leave the study before its completion.
  • Who would undertake important change in physical exercise or vigorous sport competitions during the study period.
  • Drug therapies are not permitted during the study, except contraceptive pill when applicable, with the exception of occasional use of paracetamol.
  • Any administration of treatment, which could bring about induction or inhibition of hepatic microsomal enzymes within 3 months of the study start.
  • Diabetes mellitus, Heart diseases, Kidney diseases, hypertension, asthma, Liver diseases, Chronic pancreatitis, or identified risk or known history of acute pancreatitis, Known cholelithiasis without cholecystectomy, ASAT and/or ALAT > 1.3 times ULN, Gastric or peptic ulcer or intestinal diseases, Musculoskeletal diseases or increased CK > 1.0 times ULN, History of neoplasm, Mental illness, Regular user of sedatives, hypnotics, tranquillisers or any other addictive agents or who are known to be prone to alcohol abuse (i.e. history or evidence of acute abuse), or alcohol intake >14 units per week (unit = ½ pint of beer, 1 glass of wine, 2,5 cl standard spirits), or heavy smokers (>10 cigarettes/day), or excessive drinker of tea, coffee and/or beverages containing caffeine (>8 cups/day), Blood donor with recent donation (in the three months preceding the initiation of the study) or would make blood donations during the study, Blood transfusion or administration of blood-derived products, in the year preceding the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543647

United Kingdom
Site 1
London, United Kingdom
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals Identifier: NCT00543647     History of Changes
Other Study ID Numbers: CFEN 0201
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: October 2007

Keywords provided by Solvay Pharmaceuticals:
Glomerular filtration rate
inulin clearance
healthy volunteers

Additional relevant MeSH terms:
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents