Statins in Proteinuric Nephropathies (ESPLANADE)
Chronic Nephropathy, Proteinuria, Hypertension
About this trial
This is an interventional treatment trial for Chronic Nephropathy
Eligibility Criteria
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.
Sites / Locations
- Hospital "Santa Maria della Gruccia" - Unit of Nephrology and Dialysis
- Clinical Research Center for Rare Diseases
- Hospital "S.Marte e S.Venere" - Unit of Nephrology and Dialysis
- Hospital "Santa Maria dell'Annunziata" - Unit of Nephrology
- Hospital "Casa Sollievo della Sofferenza" - Unit of Nephrology and Dialysis
- Hospital "S.Giacomo Apostolo"
- Hospital "Vittorio Emanuele II, S. Bambino, Ferrarotto" - Unit of Nephrology and Dialisys
- Hospital "Ciaccio" - Unit of Nephrolofy and Dialysis
- Hospital "Careggi Monna Tessa" - Unit of Nephrology and Dialysis
- Hospital of Padova - Unit of Nephrology and Dialysis
- Hospital "Civico e Benefratelli" - Unit of Nephrology and Hemodialysis
- Hospital of Parma - Department of Medical Clinic
- "Ospedali Riuniti" CNR I.B.I.M. - Unit of Nephrology
- University of Sassari - Institute of Medical Pathology
- Hospital "G.Mazzini" - Unit of Nephrology and Dialysis
- Hospital of Mestre - Unit of Nephrology and Dialysis
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
standard therapy
fluvastatin
Standard therapy
40-80 mg/day