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 or limiting the progression of chronic nephropathies, in addition
to limit the incidence of ESRD, may also postpone death. Drugs that inhibit the renin
angiotensin system, such as Angiotensin-Converting-Enzyme inhibitors (ACEi) and Angiotensin
II receptor antagonists (ATA), are reno- and cardio-protective in the long-term. There are
data that statins,in addition to limit cardiovascular events may have specific
reno-protective properties.
Thus we designed a study aimed to evaluate whether statins associated to ACEi and ATA may
have an additional reno-protective effect.
ESPLANADE is a multicenter, prospective, randomized, parallel group study in which, after 2
months treatment with ACEi and ATA, two groups of 90 patients, with or without type 2
diabetes, are randomized to 6 months Fluvastatin (40 or 80 mg/day) treatment YES or NO.Twenty
Italian Nephrology Units are involved in the trial. The study is fully coordinated by the
Clinical Research Center for Rare Disease Aldo e Cele Daccò, Villa Camozzi, Ranica.
Phase:
Phase 3
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research