the effects of bindarit in diabetic nephropathy

Conditions: Diabetic Nephropathy

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.

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.

Eligibility criteria:
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.

Keywords: type 2-diabetic nephrophaty bindarit albuminuria mcp-1