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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543647
• Other study ID #: CFEN 0201
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2007
• Last updated: January 16, 2015
• Start date: August 2002
• Est. completion date: March 2003

Study information

• Verified date: October 2007
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Fenofibrate 160 mg tablet

• Placebo

Locations

Country	Name	City	State
United Kingdom	Site 1	London

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	GFR evaluated by raw values of plasma creatinine and cystatin C levels		before and after each treatment period
Secondary	Renal haemodynamics evaluated by raw values of renal plasma and blood flows		before and after each treatment period
Secondary	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
Secondary	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