Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy (VICTORY)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Azienda Ospedaliero Universitaria di Sassari.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Azienda Ospedaliero Universitaria di Sassari
ClinicalTrials.gov Identifier:
NCT00861731
First received: March 12, 2009
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Hypercholesterolemia
Chronic Nephropathy
Drug: simvastatin
Drug: EZE/simvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero Universitaria di Sassari:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861731

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

No publications provided

Responsible Party: Andrea Ercole Satta, Istituto di Patologia Speciale Medica e Metodologia Clinica - AOU di Sassari
ClinicalTrials.gov Identifier: NCT00861731     History of Changes
Other Study ID Numbers: AOUSS-Nefologia-001
Study First Received: March 12, 2009
Last Updated: April 27, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliero Universitaria di Sassari:
chronic renal failure
proteinuria
apolipoprotein
c reactive protein

Additional relevant MeSH terms:
Hypercholesterolemia
Kidney Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014