Status:
COMPLETED
Statins and the Urinary Proteome
Lead Sponsor:
Universiteit Antwerpen
Conditions:
Statin Induced Proteinuria
Eligibility:
MALE
25-65 years
Phase:
NA
Brief Summary
This study aims to investigate whether statines (rosuva- and pravastatin) induce tubular proteinuria.
Detailed Description
The proximal tubular cells of the kidney are responsible for reabsorption of proteins from the tubular lumen. In a study using Opossum kidney (OK) cells, receptor-mediated protein endocytosis was redu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00464503
Start Date
September 1 2007
End Date
October 1 2007
Last Update
April 8 2008
Active Locations (1)
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1
University of Antwerp
Antwerp, Antwerp, Belgium, 2610