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

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00543647

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 I

Drug Information available for: Procetofen Inulin Creatinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
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

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
1: Experimental	Drug: Fenofibrate 160 mg tablet
2: Placebo Comparator	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

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

Study ID Numbers:	CFEN 0201
Study First Received:	October 12, 2007
Last Updated:	October 12, 2007
ClinicalTrials.gov Identifier:	NCT00543647
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

Study placed in the following topic categories:

Healthy
Procetofen

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009