Fenofibrate/Simvastatin ComparisonPhase 4NCT02886299
Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis
A Phase 4 study testing Fenofibrate and Simvastatin in people with Fenofibrate/Simvastatin Comparison, run by Cairo University.
Trial summary
Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis session. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fenofibrate/Simvastatin Comparison
- What is being tested?
- Fenofibrate and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jan 2016
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Chronic hemodialysis patients with 3 dialysis sessions per week.
- Lipid profile:
- Total Cholesterol ≥ 200 mg/dl or LDL ≥ 130 mg/dl.
- Triglycerides ≥ 150 mg/dl.
Who cannot join
- Previous intolerance to fibrates or statins.
- Use of any fibrates or statins within 6 months prior to study.
- Hypothyroidism.
- Active liver disease [unexplained persistent increase in liver enzymes (ALT \& AST > 2x ULN)].
- Uncontrolled hypertension.
- History of MI or coronary bypass surgery in last 3 months.
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- Muscle toxicity (Phosphocreatine kinase (CPK) > 2x ULN).
- Gall bladder disease.
- Use of any immunosuppressant or steroid.
About this study
Official title: Comparative Study of Effects and Safety of Intermittent Low Dose Therapy of Fenofibrate and Simvastatin on Chronic Hemodialysis Patients
Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were compared before and after 16-week treatment.
Read the detailed description
This is a prospective randomized open label parallel study.
The selected patients will be randomly allocated to one of two groups
- Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week).
- Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week).
A careful history of all patients including demographic characteristics, physical examination, chief complaint, past medical history, drug history, familial history, social history, disease(s).
Monitoring Parameters:
For efficacy, the following parameters are measured:
- Lipid profile (total cholesterol, HDL, TG and LDL from Friedwald formula [10] {LDL-C= TC-[HDL + TG\5]). (measured at baseline and every month for 4 months)
- C-reactive protein (CRP). (measured at baseline and after 4 months)
- Oxidative stress markers: oxidized LDL and human glutathione peroxidase (measured at baseline and after 4 months).
For safety: (measured at baseline and every month for 4 months)
- Observe for signs \& symptoms of muscle toxicity and measure phosphocreatine kinase (CPK).
- Liver function tests: ALT, AST, ALP \& albumin.
- Urea \& serum creatinine. (to monitor renal function)
- Hemoglobin
- Other measurements: Body mass index (BMI), Blood Pressure, electrolytes (Sodium,potassium, calcium, phosphorous) and assess patient compliance by tablet counting.
Statistical analysis will be used to compare the effects of simvastatin and fenofibrate on lipid profile, inflammatory marker (CRP) and oxidative stress markers (oxidized LDL and glutathione peroxidase). In addition, comparing their safety on renal and hepatic functions, phosphocreatine kinase, blood pressure and blood glucose level.
- Conditions
- Fenofibrate/Simvastatin Comparison
- Being tested
- Fenofibrate, Simvastatin
- Keywords
- Fibrates, Statins, Hemodialysis, Dyslipidemia, Improved Oxidative Stress, Egypt
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
SimvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate group | Active comparator | Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week). Receives: Drug: Fenofibrate |
| Simvastatin group | Active comparator | Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week). Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative stress markers (serum ox-LDL and GSH-Px)
Measured: 16 weeks
C-reactive protein
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startOct 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fenofibrate/Simvastatin ComparisonStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohammed Abdel Magid Abdel Hamid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886299
- Sponsor's protocol ID
- CL (746)
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Effects and Safety of Intermittent Low Dose Therapy of Fenofibrate and Simvastatin on Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02886299
- Acronym / sponsor ID
- CL (746)
- Conditions
- Fenofibrate/Simvastatin Comparison
- Keywords
- Fibrates, Statins, Hemodialysis, Dyslipidemia, Improved Oxidative Stress, Egypt
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Sep 2016 (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.
Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were compared before and after 16-week treatment.
Detailed description
This is a prospective randomized open label parallel study.
The selected patients will be randomly allocated to one of two groups
- Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week).
- Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week).
A careful history of all patients including demographic characteristics, physical examination, chief complaint, past medical history, drug history, familial history, social history, disease(s).
Monitoring Parameters:
For efficacy, the following parameters are measured:
- Lipid profile (total cholesterol, HDL, TG and LDL from Friedwald formula [10] {LDL-C= TC-[HDL + TG\5]). (measured at baseline and every month for 4 months)
- C-reactive protein (CRP). (measured at baseline and after 4 months)
- Oxidative stress markers: oxidized LDL and human glutathione peroxidase (measured at baseline and after 4 months).
For safety: (measured at baseline and every month for 4 months)
- Observe for signs \& symptoms of muscle toxicity and measure phosphocreatine kinase (CPK).
- Liver function tests: ALT, AST, ALP \& albumin.
- Urea \& serum creatinine. (to monitor renal function)
- Hemoglobin
- Other measurements: Body mass index (BMI), Blood Pressure, electrolytes (Sodium,potassium, calcium, phosphorous) and assess patient compliance by tablet counting.
Statistical analysis will be used to compare the effects of simvastatin and fenofibrate on lipid profile, inflammatory marker (CRP) and oxidative stress markers (oxidized LDL and glutathione peroxidase). In addition, comparing their safety on renal and hepatic functions, phosphocreatine kinase, blood pressure and blood glucose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate group | Active comparator | Drug: FenofibrateGroup I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week). |
| Simvastatin group | Active comparator | Drug: SimvastatinGroup II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Chronic hemodialysis patients with 3 dialysis sessions per week.
- Lipid profile:
Key exclusion criteria (9 listed)
- Previous intolerance to fibrates or statins.
- Use of any fibrates or statins within 6 months prior to study.
- Hypothyroidism.
- Active liver disease [unexplained persistent increase in liver enzymes (ALT \& AST > 2x ULN)].
- Uncontrolled hypertension.
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 | Drug | Fenofibrate group |
| Simvastatin | Drug | Simvastatin group |
Primary outcome
oxidative stress markers (serum ox-LDL and GSH-Px)
Time frame: 16 weeks
C-reactive protein
Time frame: 16 weeks
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 5 Sep 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenofibrate and Simvastatin in people with Fenofibrate/Simvastatin Comparison, run by Cairo University.
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 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
oxidative stress markers (serum ox-LDL and GSH-Px) (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 5 Sep 2016.