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The purpose of this study is to determine whether bindarit is effective to reduce albuminuria, compared to placebo, in nephropathic patients treated with irbesartan, as a background therapy.
This is a pilot phase II, double-blind, multicentre, randomized, placebo-controlled, parallel groups study in patients with DN undergoing irbesartan therapy.
According to screening urinary albumin excretion, at baseline and before randomization, all patients will be categorized into 2 strata:
Stratum 1: microalbuminuria (20 to 200 μg/min, in at least 2 of 3 consecutive overnight urine samples collected at the screening) Stratum 2: macroalbuminuria (>200 μg/min, in at least 2 of 3 consecutive overnight urine samples collected at the screening).
Within each stratum, patients will be randomly allocated on a 1:1 basis to the 2 treatment arms (after one month induction period):
- bindarit 600MG twice a day
- placebo All patients will be treated with irbesartan 300 mg/day as background therapy. After 12 months of treatment albuminuria will be evaluated as primary endopoint.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The Mario Negri Institute for Pharmacological Research- Clinical Research Center for Rare Diseases
Aziende Chimiche Riunite Angelini Francesco S.p.A
Published on BioPortfolio: 2014-08-27T03:14:13-0400
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