HypercholesterolemiaPhase 4VICTORYNCT00861731
Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy
A Phase 4 study testing simvastatin and EZE/simvastatin in people with Hypercholesterolemia and Chronic Nephropathy, run by Azienda Ospedaliero Universitaria di Sassari at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether, in patients with chronic proteinuric nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than statin alone to achieve the optimum lipid control, and if this translates to an improvement of the markers of vascular damage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia, Chronic Nephropathy
- What is being tested?
- simvastatin and EZE/simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2008to Jul 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years
- LDL-cholesterol > 100 mg/dl (without concomitant hypolipidemic drugs) in patients whit high cardiovarscular risk for the concomitant presence of:
- proteinuric chronic nephropathy defined as creatinine clearance > 20 ml/min/1,73 m2 combined to a urinary protein excretion rate > 0,3 g/24h, without evidence of urinary tract infection or overt heart failure (New York Heart Association class III or more)
- hypertension defined as a systolic or diastolic blood pressure > 140 or 90 mmHg respectively (or less in patients with concomitant antihypertensive therapy)
Who cannot join
- previous or concomitant treatment with steroids, anti-inflammatory and immunosuppressive agents
- evidence or suspicion of renovascular disease, obstructive uropathy, type I diabetes mellitus, vasculitides, history of poor tolerance or allergy to ACEi and ATA, statin or EZE, drug abuse or pregnancy
- inability to fully understand the purposes/risks of the study and to provide a written informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto di Patologia Medica - Azienda Ospedaliero Universitaria
Sassari, 07100
About this study
Official title: The Metabolic and Anti-Inflammatory Effects of Combined Ezetimibe and Simvastin Therapy, as Compared to Simvastatin Alone, in Patients With Chronic Proteinuric Nephropathy
The purpose of this study is to determine whether, in patients with chronic proteinuric nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than statin alone to achieve the optimum lipid control, and if this translates to an improvement of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).
Read the detailed description
Patients with chronic kidney disease (CKD) have an increased incidence of cardiovascular morbidity and mortality. Presence of hypertension, lipid abnormalities and inflammation each contribute to increased cardiovascular risk. Therefore blood pressure control slows the progression of CKD towards End Stage Renal Failure (ESRF) improving clinical outcome.
Instead the contribution of lipid abnormalities is still not completely understood, mainly because dyslipidemia interferes with a number of non-traditional cardiovascular risk factors, particularly the activated acute-phase response.
In proteinuric patients, dyslipidemia has a highly atherogenic profile, with increased total and low-density lipoprotein (LDL) cholesterol, triglyceride, and lipoprotein(a) serum levels, as well as decreased HDL cholesterol. Numerous studies have indicated that treatment of dyslipidemia with a statin decreases cardiovascular morbidity and mortality. Experimental and clinical evidences show that statin, in addition to ameliorate lipid profile, may have specific renoprotective properties and, combined to Renin-Angiotensin System (RAS) inhibitor therapy, may synergize their antiproteinuric effects.
Preliminary data are also available data that the combination of statin to ezetimibe (EZE), a cholesterol absorption inhibitor, produces an additional decrease in LDL cholesterol and C-reactive protein levels, over that achieved with statin monotherapy.
Thus, adding the potential antinflammatory effect to hypolipidemic efficacy, combined therapy may expand the renal and cardioprotective potentiality. It may also permit a reduction of statin therapeutic dose improving safety profile. Therefore EZE-statin combination therapy may be an effective therapeutic option to statin alone in patients with high cardiovascular risk, such as chronic proteinuric patients.
- Conditions
- Hypercholesterolemia, Chronic Nephropathy
- Being tested
- simvastatin, EZE/simvastatin
- Keywords
- chronic renal failure, proteinuria, apolipoprotein, c reactive protein
- Medical subject headings
- Hypercholesterolemia, Kidney Failure, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
simvasatin therapy alone at the dose of 40 mg/day
EZE/simvastatinDrug
EZE/simvastatin combined therapy at the dose of 10/20 mg/day
EZE/simvastatinDrug
EZE/simvastatin combined therapy at the dose of 10/40 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | hypolipidemic treatment Receives: Drug: simvastatin |
| 2 | Sham comparator | hypolipidemic treatment Receives: Drug: EZE/simvastatin |
| 3 | Sham comparator | hypolipidemic treatment Receives: Drug: EZE/simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether EZE-statin combined therapy is more effective than statin alone to achieve the optimum lipid control (LDL-cholesterol < 70 mg/dl) in chronic proteinuric nephropathy.
Measured: at baseline and every 4 months after therapy start
Secondary outcomes (1)
To assess the effect of EZE-statin combined therapy vs statin monotherapy on other outcome variables including: - renal parameters - inflammatory status - markers of endothelial dysfunction
Measured: after one year observational period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startNov 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria di Sassari
- Sponsor type
- University, hospital or other
- Investigators
- Andrea E Satta, MD, Principal investigator, Istituto di Patologia Medica -Azienda Ospedaliero Universitaria di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861731
- Sponsor's protocol ID
- AOUSS-Nefologia-001
- Acronym
- VICTORY
- Status last verified
- Apr 2009
- First submitted
- 12 Mar 2009
- Last updated
- 28 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
PubMed 38018702Zinellu A, Sotgia S, Sotgiu E, Assaretti S, Baralla A, Mangoni AA, Satta AE, Carru C. Cholesterol lowering treatment restores blood global DNA methylation in chronic kidney disease (CKD) patients. Nutr Metab Cardiovasc Dis. 2017 Sep;27(9):822-829. doi: 10.1016/j.numecd.2017.06.011. Epub 2017 Jun 28.
PubMed 28755807
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic and Anti-Inflammatory Effects of Combined Ezetimibe and Simvastin Therapy, as Compared to Simvastatin Alone, in Patients With Chronic Proteinuric Nephropathy
- ClinicalTrials.gov ID
- NCT00861731
- Acronym / sponsor ID
- VICTORY / AOUSS-Nefologia-001
- Conditions
- Hypercholesterolemia, Chronic Nephropathy
- Keywords
- chronic renal failure, proteinuria, apolipoprotein, c reactive protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria di SassariUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 13 Mar 2009 (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 is to determine whether, in patients with chronic proteinuric nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than statin alone to achieve the optimum lipid control, and if this translates to an improvement of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).
Detailed description
Patients with chronic kidney disease (CKD) have an increased incidence of cardiovascular morbidity and mortality. Presence of hypertension, lipid abnormalities and inflammation each contribute to increased cardiovascular risk. Therefore blood pressure control slows the progression of CKD towards End Stage Renal Failure (ESRF) improving clinical outcome.
Instead the contribution of lipid abnormalities is still not completely understood, mainly because dyslipidemia interferes with a number of non-traditional cardiovascular risk factors, particularly the activated acute-phase response.
In proteinuric patients, dyslipidemia has a highly atherogenic profile, with increased total and low-density lipoprotein (LDL) cholesterol, triglyceride, and lipoprotein(a) serum levels, as well as decreased HDL cholesterol. Numerous studies have indicated that treatment of dyslipidemia with a statin decreases cardiovascular morbidity and mortality. Experimental and clinical evidences show that statin, in addition to ameliorate lipid profile, may have specific renoprotective properties and, combined to Renin-Angiotensin System (RAS) inhibitor therapy, may synergize their antiproteinuric effects.
Preliminary data are also available data that the combination of statin to ezetimibe (EZE), a cholesterol absorption inhibitor, produces an additional decrease in LDL cholesterol and C-reactive protein levels, over that achieved with statin monotherapy.
Thus, adding the potential antinflammatory effect to hypolipidemic efficacy, combined therapy may expand the renal and cardioprotective potentiality. It may also permit a reduction of statin therapeutic dose improving safety profile. Therefore EZE-statin combination therapy may be an effective therapeutic option to statin alone in patients with high cardiovascular risk, such as chronic proteinuric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: simvastatinhypolipidemic treatment |
| 2 | Sham comparator | Drug: EZE/simvastatinhypolipidemic treatment |
| 3 | Sham comparator | Drug: EZE/simvastatinhypolipidemic treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >18 years
- LDL-cholesterol > 100 mg/dl (without concomitant hypolipidemic drugs) in patients whit high cardiovarscular risk for the concomitant presence of:
- proteinuric chronic nephropathy defined as creatinine clearance > 20 ml/min/1,73 m2 combined to a urinary protein excretion rate > 0,3 g/24h, without evidence of urinary tract infection or overt heart failure (New York Heart Association class III or more)
- hypertension defined as a systolic or diastolic blood pressure > 140 or 90 mmHg respectively (or less in patients with concomitant antihypertensive therapy)
Key exclusion criteria (3 listed)
- previous or concomitant treatment with steroids, anti-inflammatory and immunosuppressive agents
- evidence or suspicion of renovascular disease, obstructive uropathy, type I diabetes mellitus, vasculitides, history of poor tolerance or allergy to ACEi and ATA, statin or EZE, drug abuse or pregnancy
- inability to fully understand the purposes/risks of the study and to provide a written informed consent
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 |
|---|---|---|
| simvastatinsimvasatin therapy alone at the dose of 40 mg/day | Drug | 1 |
| EZE/simvastatinEZE/simvastatin combined therapy at the dose of 10/20 mg/day | Drug | 2 |
| EZE/simvastatinEZE/simvastatin combined therapy at the dose of 10/40 mg/day | Drug | 3 |
Primary outcome
To assess whether EZE-statin combined therapy is more effective than statin alone to achieve the optimum lipid control (LDL-cholesterol < 70 mg/dl) in chronic proteinuric nephropathy.
Time frame: at baseline and every 4 months after therapy start
1 secondary outcome
To assess the effect of EZE-statin combined therapy vs statin monotherapy on other outcome variables including: - renal parameters - inflammatory status - markers of endothelial dysfunction
Time frame: after one year observational period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2009.
- Derived from this study: PubMed 38018702Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
- Derived from this study: PubMed 28755807Zinellu A, Sotgia S, Sotgiu E, Assaretti S, Baralla A, Mangoni AA, Satta AE, Carru C. Cholesterol lowering treatment restores blood global DNA methylation in chronic kidney disease (CKD) patients. Nutr Metab Cardiovasc Dis. 2017 Sep;27(9):822-829. doi: 10.1016/j.numecd.2017.06.011. Epub 2017 Jun 28.
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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.
Andrea E Satta, MD principal investigator
Istituto di Patologia Medica -Azienda Ospedaliero Universitaria di Sassari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing simvastatin and EZE/simvastatin in people with Hypercholesterolemia and Chronic Nephropathy, run by Azienda Ospedaliero Universitaria di Sassari at 1 site in Italy.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Apr 2009. 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 Italy. 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 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?
Results are not available in the source record.
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?
To assess whether EZE-statin combined therapy is more effective than statin alone to achieve the optimum lipid control (LDL-cholesterol < 70 mg/dl) in chronic proteinuric nephropathy. (time frame: at baseline and every 4 months after therapy start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861731, which also lists 2 linked publications.
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 28 Apr 2009; AzTrials last refreshed its copy on 1 Nov 2026.