The Effects of Bindarit in Diabetic Nephropathy

Aziende Chimiche Riunite Angelini Francesco S.p.A100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Diabetic Nephropathy

Interventions

BindaritDRUG

dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks

PlaceboDRUG

dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

INCLUSION CRITERIA * male and female patients with no limitation of race, aged 30 to 70 years; * Type 2 diabetes defined as: \> 30 years of age at diagnosis; insulin not required within 6 months of initial diagnosis; no history of diabetic ketoacidosis; currently treated with diet, oral hypoglycemics or insulin \[Brenner 2000\]; * microalbuminuria defined as urinary albumin excretion, 20 to 200 µg/min in at least 2 of 3 overnight urine samples or macroalbuminuria defined as urinary albumin excretion, \> 200 µg/min in at least 2 of 3 overnight urine samples, confirmed in the baseline collection; should baseline albuminuria data not to be available, the patient may be conditionally treated; * glycosylated haemoglobin (Hb A1c) \<12% at Screening \[Brenner 2000\]; * serum creatinine ≤ 3 mg/dL at Screening; * normotensive patients or hypertensive patients on stable antihypertensive therapy over the last 3 months and without specific contraindications to angiotensin antagonist therapy; * female patients of childbearing potential required to have a negative pregnancy test and use an approved birth control method; * patients legally able to give written informed consent to the trial (signed and dated by the patient). EXCLUSION CRITERIA Patients cannot enter the trial under the following circumstances: * patients hypersensitive or allergic to ARBs or bindarit or its components, or with a positive history for drug allergy; * Type 1 diabetes \[Brenner 2000\]; * history of non diabetic renal disease, including renal artery stenosis \[Brenner 2000\]; * history of heart failure before enrolment \[Brenner 2000\]; * acute myocardial infarction, coronary artery bypass grafting within the past one month \[Brenner 2000\]; * cerebral vascular accident or coronary angioplasty within the past six months month \[Brenner 2000\]; * Transient Ischemic Attacks (TIA) in the past 12 months \[Brenner 2000\]; * primary aldosteronism or pheocromocytoma \[Brenner 2000\]; * severe uncontrolled hypertension (sitting diastolic blood pressure \> 115 and/or sitting systolic blood pressure\> 220 mm Hg) in the previous 6 months; * chronic use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressive drugs, MAO inhibitors; * patients under the influence of alcohol or narcotics; * patients treated with experimental drugs in the previous 4 weeks.

Locations (6)

Azienda Ospedaliera OO.RR. Bergamo - Unità Operativa Diabetologia

Bergamo, Bergamo, 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

Outcomes

Primary Outcomes

Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen.

Relative change (per cent change) in Urinary Albumin Excretion (UAE) from the baseline

Time frame: 12 weeks

Secondary Outcomes

Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen.

Relative change (per cent change) in Urinary MCP-1 levels from the baseline.

Time frame: 12 weeks

Serum lipids

Relative change (per cent change) in total cholesterol, cholesterol HDL, triglycerides, apolipoprotein-A, apolipoprotein-B from the baseline.

Time frame: 12 weeks

Safety and tolerability of bindarit in association of irbesartan.

Changes in anthropometrics, laboratory parameters and vital signs from the baseline. Number of adverse events.

Time frame: 12 weeks

Albuminuria remission rates

Rate of remission from macro to microalbuminuria and from micro to normoalbuminuria.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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