Effects of Atorvastatin Versus Probucol on Small Dense LDL

Chronic Nephropathy Clinical Trial

Official title:

Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276133
• Other study ID #: 7332-1
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2006
• Last updated: May 8, 2007
• Start date: January 2004
• Est. completion date: May 2007

Study information

• Verified date: May 2007
• Source: Yokohama City University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular injury through conversion to an oxidatively modified form of LDL. However, few studies evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective actions in hyperlipidemic patients with non-diabetic nephropathy.

Description:

The study is a randomized crossover trial comparing the effect of atorvastatin (10 mg/day) and probucol (500 mg/day) for 24 weeks in 30 patients (urinary albumin excretion 0.3–2.0 g/day, and creatinine clearance > 30 ml/min/1.73 m2 or serum creatinine concentration < 2 mg/L). Lipid parameters, mean LDL particle diameter, creatinine clearance, and urinary albumin to creatinine excretion ratio are measured before and during treatment periods. It will be evaluated that, first, whether atorvastatin and probucol significantly reduce serum total cholesterol and LDL cholesterol concentrations, second, whether atorvastatin and probucol significantly increase the LDL particle size, third, whether significant differences in urinary albumin/creatinine excretion ratio and creatinine clearance are observed in both groups during treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hyperlipidemic patients with non-diabetic nephropathy

Exclusion Criteria:

• Endocrinological, hematological or hepatic disease

• Cerebral infarction or hemorrhage

• Homozygous familial hypercholesterolemia

• Uncontrolled hypertension

• Myocardial infarction occurring within the previous 6 months

• Unstable angina

• Diabetic nephropathy

• Abnormal thyroid function

• Receiving steroids or immunosuppressive agents

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Effects of atorvastatin versus probucol on small dense LDL

Locations

Country	Name	City	State
Japan	Yokohama City University Center Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Yasuda G, Kuji T, Hasegawa K, Ogawa N, Shimura G, Ando D, Umemura S. Safety and efficacy of fluvastatin in hyperlipidemic patients with chronic renal disease. Ren Fail. 2004 Jul;26(4):411-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalization of serum cholesterol concentrations		One year