Status:
COMPLETED
Statins in Proteinuric Nephropathies
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Chronic Nephropathy
Proteinuria
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief Summary
End stage renal disease (ESRD) is rapidly growing worldwide. Patients with ESRD have increased morbidity and mortality mostly because of a dramatic excess of cardiovascular disease. Thus, preventing o...
Detailed Description
INTRODUCTION End stage renal disease (ESRD) is rapidly growing worldwide and costs of providing ESRD care will soon outstrip the available resources. In addition to a poor quality of life, patients wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- age \>16 years
- hypertension, defined as a systolic or diastolic blood pressure \> 140 or 90 mmHg respectively (or less in patients with concomitant antihypertensive therapy)
- creatinine clearance \>20 ml/min/1.73m2 (with variation of less than 30% in the 3 months prior to study entry)
- urinary protein excretion rate persistently \> 1 g/24 hours (average of at least two measurements in two urine collections two weeks apart) without evidence of urinary tract infection or overt heart failure (New York Heart Association class III or more)
- written informed consent
- Exclusion criteria:
- specific contraindication to statin therapy because of a previous coronary event or serum LDL-cholesterol levels \> 190 mg/dL despite a low cholesterol (\<200 mg/day) diet and a saturated fatty acid in take less than 7% of total calories will not be included
- chronic treatment with corticosteroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive drugs
- acute myocardial infarction or cerebrovascular accident in the six months preceding the study - severe uncontrolled hypertension (diastolic blood pressure \>115 and/or systolic blood pressure \>220 mmHg)
- evidence or suspicion of renovascular disease, obstructive uropathy, type 1 diabetes mellitus, vasculitides, cancer
- elevated serum aminotransferase concentrations - chronic cough
- history of poor tolerance or allergy to ACEi, ATA or statins
- drug or alcohol abuse
- pregnancy, breast feeding and ineffective contraception
- legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00199927
Start Date
March 1 2003
End Date
March 1 2008
Last Update
April 28 2010
Active Locations (16)
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1
Hospital "Santa Maria della Gruccia" - Unit of Nephrology and Dialysis
Montevarchi, Arezzo, Italy, 52100
2
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
3
Hospital "S.Marte e S.Venere" - Unit of Nephrology and Dialysis
Acireale, Catania, Italy, 95024
4
Hospital "Vittorio Emanuele II, S. Bambino, Ferrarotto" - Unit of Nephrology and Dialisys
Catania, Catania, Italy, 95100