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Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy (VICTORY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Azienda Ospedaliero Universitaria di Sassari

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Chronic Nephropathy Drug: simvastatin Drug: EZE/simvastatin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: 1
hypolipidemic treatment
Drug: simvastatin
simvasatin therapy alone at the dose of 40 mg/day

Sham Comparator: 2
hypolipidemic treatment
Drug: EZE/simvastatin
EZE/simvastatin combined therapy at the dose of 10/20 mg/day

Sham Comparator: 3
hypolipidemic treatment
Drug: EZE/simvastatin
EZE/simvastatin combined therapy at the dose of 10/40 mg/day

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: after one year observational period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00861731

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Istituto di Patologia Medica - Azienda Ospedaliero Universitaria
Sassari, Italy, 07100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria di Sassari
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Principal Investigator: Andrea E Satta, MD Istituto di Patologia Medica -Azienda Ospedaliero Universitaria di Sassari

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Andrea Ercole Satta, Istituto di Patologia Speciale Medica e Metodologia Clinica - AOU di Sassari Identifier: NCT00861731    
Other Study ID Numbers: AOUSS-Nefologia-001
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009
Keywords provided by Azienda Ospedaliero Universitaria di Sassari:
chronic renal failure
c reactive protein
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors