Effect of Fenofibrate on Kidney Function: a Six-week Randomized Cross-over Trial in Healthy People
Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Fenofibrate 160 mg tablet (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s): Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Glomerular filtration rate (GFR) assessed by the measure of inulin clearance
Secondary outcome: GFR evaluated by raw values of plasma creatinine and cystatin C levelsRenal haemodynamics evaluated by raw values of renal plasma and blood flows Tubular function: creatinine clearance, albuminuria, urine N-acetyl Beta D glucosaminidase and Retinol Binding Protein, sodium clearance and sodium fractional excretion 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
Eligibility
Minimum age: 30 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Site 1, London, United Kingdom
Additional Information
Starting date: August 2002
Last updated: January 16, 2015
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