The Effects of Bindarit in Diabetic Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT01109212
• Date of registration: 08/04/2010
• Prospective Registration: No
• Primary sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Public title: The Effects of Bindarit in Diabetic Nephropathy
• Scientific title: The Effects of the Association Bindarit + Irbesartan Versus Irbesartan Alone on Albuminuria on Patients With Diabetic Nephropathy. Placebo-controlled Study
• Date of first enrolment: March 2007
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01109212
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Italy, Slovenia

Contacts

• Name: Giuseppe Remuzzi, PhD
• Affiliation: Mario Negri Institute for Pharmacological Research

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Nephropathy

Intervention(s)

Drug: Bindarit

Drug: Placebo

Primary Outcome(s)

Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen. [Time Frame: 12 weeks]

Secondary Outcome(s)

Albuminuria remission rates [Time Frame: 12 weeks]

Serum lipids [Time Frame: 12 weeks]

Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen. [Time Frame: 12 weeks]

Safety and tolerability of bindarit in association of irbesartan. [Time Frame: 12 weeks]

Secondary ID(s)

004SC06084

2006-006191-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mario Negri Institute for Pharmacological Research