The Effects of Bindarit in Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Official title:

The Effects of the Association Bindarit + Irbesartan Versus Irbesartan Alone on Albuminuria on Patients With Diabetic Nephropathy. Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109212
• Other study ID #: 004SC06084
• Secondary ID: 2006-006191-38
• Status: Completed
• Phase: Phase 2
• First received: April 8, 2010
• Last updated: March 29, 2016
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2016
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencySlovenia: Agency for Medicinal Products - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Bindarit
dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks
• Placebo
dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera OO.RR. Bergamo - Unità Operativa Diabetologia	Bergamo
Italy	IRCCS Fondazione Centro S. Raffaele del Monte Tabor- Unità Operativa Medicina Generale	Milano
Italy	The Mario Negri Institute for Pharmacological Research- Clinical Research Center for Rare Diseases	Ranica	Bergamo
Italy	Ist. Patologia Medica e metodologia Clinica - Università di Sassari	Sassari
Italy	Azienda Ospedaliera di Treviglio-Caravaggio - Unità Operativa Malattie Metaboliche e Diabetologia	Treviglio	Bergamo
Slovenia	University Medical Center Dpt Endocrinology Diabetes and Metabolic Diseases- Diabetology Unit	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
Aziende Chimiche Riunite Angelini Francesco S.p.A	Mario Negri Institute for Pharmacological Research

Countries where clinical trial is conducted

Italy,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen.	Relative change (per cent change) in Urinary Albumin Excretion (UAE) from the baseline	12 weeks	No
Secondary	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.	12 weeks	No
Secondary	Serum lipids	Relative change (per cent change) in total cholesterol, cholesterol HDL, triglycerides, apolipoprotein-A, apolipoprotein-B from the baseline.	12 weeks	No
Secondary	Safety and tolerability of bindarit in association of irbesartan.	Changes in anthropometrics, laboratory parameters and vital signs from the baseline. Number of adverse events.	12 weeks	Yes
Secondary	Albuminuria remission rates	Rate of remission from macro to microalbuminuria and from micro to normoalbuminuria.	12 weeks	No

External Links

•   Sponsor's website