NCT01109212

The Effects of Bindarit in Diabetic Nephropathy

The Effects of the Association Bindarit + Irbesartan Versus Irbesartan Alone on Albuminuria on Patients With Diabetic Nephropathy. Placebo-controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Bindarit	dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks
DRUG	Placebo	dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2010-04-23
• Last updated: 2016-03-30

Locations

6 sites across 2 countries: Italy, Slovenia