Healthy VolunteersPhase 1NCT00543647
Effect of Fenofibrate on Kidney Function: a Six-week Randomized Cross-over Trial in Healthy People
A Phase 1 study testing Fenofibrate 160 mg tablet in people with Healthy Volunteers, run by Solvay Pharmaceuticals at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Fenofibrate 160 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2002to Mar 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Fenofibrate 160 mg tablet, Placebo
- Keywords
- Fenofibrate, Glomerular filtration rate, inulin clearance, creatinine, healthy volunteers, cross-over
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate 160 mg tabletDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fenofibrate 160 mg tablet |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (GFR) assessed by the measure of inulin clearance
Measured: 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
Measured: before and after each treatment period
Renal haemodynamics evaluated by raw values of renal plasma and blood flows
Measured: 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
Measured: 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
Measured: before and after each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startAug 2002
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543647
- Sponsor's protocol ID
- CFEN 0201
- Status last verified
- Oct 2007
- First submitted
- 12 Oct 2007
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00543647
- Acronym / sponsor ID
- CFEN 0201
- Conditions
- Healthy Volunteers
- Keywords
- Fenofibrate, Glomerular filtration rate, inulin clearance, creatinine, healthy volunteers, cross-over
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Mar 2003 (actual)
- First posted
- 15 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fenofibrate 160 mg tablet |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate 160 mg tablet | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
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
4 secondary outcomes
GFR evaluated by raw values of plasma creatinine and cystatin C levels
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fenofibrate 160 mg tablet in people with Healthy Volunteers, run by Solvay Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.