Statins and the Urinary Proteome

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study aims to investigate whether statines (rosuva- and pravastatin) induce tubular proteinuria.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universiteit Antwerpen
• Treatments: Pravastatin; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Male, age range: 25 - 65 years

• Non-smoker

• Proteinuria: < 60 mg/24 hours

• Dipstick negative hematuria

• Bloodpressure: < 135 mm systolic, < 85 mm dyastolic

• Waist circumference: < 94 cm

Exclusion Criteria:

• Treatment with lipid-lowering drugs <1 year prior to the study

• Known history of diabetes or fasting glucose level: < 110 mg/dl

• Anti-hypertensive medication

• Life-expectancy < 1 year

• Pharmacological treatment with inotropes

• Acute or chronic inflammatory process, use if anti-inflammatory drugs or immunosuppression

• Clinically active malignant disease

• Administration of any investigational drug within 30 days preceding study start and during the study

• Known intolerance to rosuvastatin or other statins

• Acute or chronic liver disease or ALAT>2.0 x upper limit of normal (ULN) at enrolment visit.

• Chronic muscle disease such as dermatomyositis or polymyositis or unexplained creatinine kinase (CK) above 3 x ULN at enrolment.

• Uncontrolled hypothyroidism as indicated by a thyroid stimulating hormone (TSH) > 2 x ULN at enrolment.

• Renal insufficiency: creatinine > 2.0mg/dl

• Known or suspect alcohol or drug abuse.