Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy

NCT00861731 | Unknown Phase 4 DMC

• 1 other identifier: AOUSS-Nefologia-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypercholesterolemia; Chronic Nephropathy

Keywords

chronic renal failure; proteinuria; apolipoprotein; c reactive protein

Outcome Measures

Primary Outcomes (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.

  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

  after one year observational period

Study Arms (3)

1

ACTIVE COMPARATOR

hypolipidemic treatment

Drug: simvastatin

2

SHAM COMPARATOR

hypolipidemic treatment

Drug: EZE/simvastatin

3

SHAM COMPARATOR

hypolipidemic treatment

Drug: EZE/simvastatin

Interventions

simvastatin DRUG

simvasatin therapy alone at the dose of 40 mg/day

1

EZE/simvastatin DRUG

EZE/simvastatin combined therapy at the dose of 10/20 mg/day

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria di Sassari: lead

Study Sites (1)

Istituto di Patologia Medica - Azienda Ospedaliero Universitaria

Sassari, 07100, Italy

Location

Related Publications (2)

• 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.

  PMID: 38018702 DERIVED

• Zinellu 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.

  PMID: 28755807 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Kidney Failure, Chronic; Proteinuria

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Andrea E Satta, MD

  Istituto di Patologia Medica -Azienda Ospedaliero Universitaria di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 28, 2009

Record last verified: 2009-04

Locations

IT (1)