The Effects of Bindarit in Diabetic Nephropathy

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Collaborator: Mario Negri Institute for Pharmacological Research
• Treatments: Bindarit; Irbesartan

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.