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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00543647
First received: October 12, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Fenofibrate 160 mg tablet
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • GFR evaluated by raw values of plasma creatinine and cystatin C levels [ Time Frame: before and after each treatment period ]
  • Renal haemodynamics evaluated by raw values of renal plasma and blood flows [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: before and after each treatment period ]

Enrollment: 24
Study Start Date: August 2002
Study Completion Date: March 2003
Arms Assigned Interventions
Experimental: 1 Drug: Fenofibrate 160 mg tablet
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00543647

Locations
United Kingdom
Site 1
London, United Kingdom
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00543647     History of Changes
Other Study ID Numbers: CFEN 0201
Study First Received: October 12, 2007
Last Updated: October 12, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Solvay Pharmaceuticals:
Fenofibrate
Glomerular filtration rate
inulin clearance
creatinine
healthy volunteers
cross-over

Additional relevant MeSH terms:
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014