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

NCT00543647 | Completed Phase 1

• 1 other identifier: CFEN 0201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Fenofibrate; Glomerular filtration rate; inulin clearance; creatinine; healthy volunteers; cross-over

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: Fenofibrate 160 mg tablet

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Fenofibrate 160 mg tablet DRUG

1

Placebo DRUG

2

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Solvay Pharmaceuticals: lead

Study Sites (1)

Site 1

London, United Kingdom

Location

MeSH Terms

Interventions

Fenofibrate; Tablets

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Global Clinical Director Solvay

  Solvay Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 12, 2007
• First Posted: October 15, 2007
• Study Start: August 1, 2002
• Study Completion: March 1, 2003
• Last Updated: January 19, 2015

Record last verified: 2007-10

Locations

GB (1)