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

January 16, 2015 updated by: Solvay Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: Fenofibrate 160 mg tablet
Placebo Comparator: 2
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glomerular filtration rate (GFR) assessed by the measure of inulin clearance
Time Frame: After two periods of 6 weeks treatment (fenofibrate and placebo in cross-over) separated by a 6wks wash out
After two periods of 6 weeks treatment (fenofibrate and placebo in cross-over) separated by a 6wks wash out

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
GFR evaluated by raw values of plasma creatinine and cystatin C levels
Time Frame: before and after each treatment period
before and after each treatment period
Renal haemodynamics evaluated by raw values of renal plasma and blood flows
Time Frame: before and after each treatment period
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
Time Frame: before and after each treatment period
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
Time Frame: before and after each treatment period
before and after each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CFEN 0201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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