The Effects of Bindarit in Diabetic Nephropathy

Phase 2

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: Bindarit; Drug: Placebo

• Registration Number: NCT01109212
• Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

Brief 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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bindarit	Bindarit	Patients treated with bindarit 2x300 mg bid plus irbesartan 2x150 mg once a day for 12 weeks
Placebo	Placebo	patients treated with placebo 2 tablets bid plus irbesartan 2x150 mg once a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen.	12 weeks	Relative change (per cent change) in Urinary Albumin Excretion (UAE) from the baseline

Secondary Outcome Measures

Name	Time	Method
Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen.	12 weeks	Relative change (per cent change) in Urinary MCP-1 levels from the baseline.
Serum lipids	12 weeks	Relative change (per cent change) in total cholesterol, cholesterol HDL, triglycerides, apolipoprotein-A, apolipoprotein-B from the baseline.
Safety and tolerability of bindarit in association of irbesartan.	12 weeks	Changes in anthropometrics, laboratory parameters and vital signs from the baseline. Number of adverse events.
Albuminuria remission rates	12 weeks	Rate of remission from macro to microalbuminuria and from micro to normoalbuminuria.

Trial Locations

Locations (6)

University Medical Center Dpt Endocrinology Diabetes and Metabolic Diseases- Diabetology Unit; 🇸🇮 Ljubljana, Slovenia

Azienda Ospedaliera OO.RR. Bergamo - Unità Operativa Diabetologia; 🇮🇹 Bergamo, Italy

IRCCS Fondazione Centro S. Raffaele del Monte Tabor- Unità Operativa Medicina Generale; 🇮🇹 Milano, Italy

Ist. Patologia Medica e metodologia Clinica - Università di Sassari; 🇮🇹 Sassari, Italy

The Mario Negri Institute for Pharmacological Research- Clinical Research Center for Rare Diseases; 🇮🇹 Ranica, Bergamo, Italy

Azienda Ospedaliera di Treviglio-Caravaggio - Unità Operativa Malattie Metaboliche e Diabetologia; 🇮🇹 Treviglio, Bergamo, Italy