Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Volunteers

Keywords

FenofibrateGlomerular filtration rateinulin clearancecreatininehealthy volunteerscross-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 tabletDrug

PlaceboDrug

Eligibility Criteria

Age30 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male and female
Age: 30-60 years old

Sponsors & Collaborators

Solvay Pharmaceuticals
Industrylead

Study Sites (1)

Site 1

London, United Kingdom

MeSH Terms

Interventions

FenofibrateTablets

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

Global Clinical Director Solvay
Solvay Pharmaceuticals
STUDY DIRECTOR

Enrollment

24 participants (actual enrollment reported by the registry).

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 2002

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations