Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy (VICTORY)
|ClinicalTrials.gov Identifier: NCT00861731|
Recruitment Status : Unknown
Verified April 2009 by Azienda Ospedaliero Universitaria di Sassari.
Recruitment status was: Active, not recruiting
First Posted : March 13, 2009
Last Update Posted : April 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Chronic Nephropathy||Drug: simvastatin Drug: EZE/simvastatin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||July 2009|
Active Comparator: 1
simvasatin therapy alone at the dose of 40 mg/day
Sham Comparator: 2
EZE/simvastatin combined therapy at the dose of 10/20 mg/day
Sham Comparator: 3
EZE/simvastatin combined therapy at the dose of 10/40 mg/day
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861731
|Istituto di Patologia Medica - Azienda Ospedaliero Universitaria|
|Sassari, Italy, 07100|
|Principal Investigator:||Andrea E Satta, MD||Istituto di Patologia Medica -Azienda Ospedaliero Universitaria di Sassari|