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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: Fenofibrate 160 mg tablet

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Fenofibrate 160 mg tablet
Placebo Comparator: 2	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
GFR evaluated by raw values of plasma creatinine and cystatin C levels	before and after each treatment period
Renal haemodynamics evaluated by raw values of renal plasma and blood flows	before and after each treatment period
Tubular function: creatinine clearance, albuminuria, urine N-acetyl Beta D glucosaminidase and Retinol Binding Protein, sodium clearance and sodium fractional excretion	before and after each treatment period
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	before and after each treatment period

Collaborators and Investigators

• Sponsor: Solvay Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: October 12, 2007
• First Submitted That Met QC Criteria: October 12, 2007
• First Posted (Estimate): October 15, 2007

Study Record Updates

• Last Update Posted (Estimate): January 19, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: healthy volunteers; Glomerular filtration rate; cross-over; Fenofibrate; creatinine; inulin clearance
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: CFEN 0201