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

Sponsor

Solvay Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00543647

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Aug 1, 2002

Actual Study Completion Date :

Mar 1, 2003

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: Fenofibrate 160 mg tablet

Placebo Comparator: 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

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.