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The Effects of Bindarit in Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bindarit
Placebo
Sponsored by
Aziende Chimiche Riunite Angelini Francesco S.p.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Type 2-Diabetic Nephrophaty, bindarit, albuminuria, MCP-1

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bindarit

Placebo

Arm Description

Patients treated with bindarit 2x300 mg bid plus irbesartan 2x150 mg once a day for 12 weeks

patients treated with placebo 2 tablets bid plus irbesartan 2x150 mg once a day for 12 weeks

Outcomes

Primary Outcome Measures

Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen.
Relative change (per cent change) in Urinary Albumin Excretion (UAE) from the baseline

Secondary Outcome Measures

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.
Serum lipids
Relative change (per cent change) in total cholesterol, cholesterol HDL, triglycerides, apolipoprotein-A, apolipoprotein-B from the baseline.
Safety and tolerability of bindarit in association of irbesartan.
Changes in anthropometrics, laboratory parameters and vital signs from the baseline. Number of adverse events.
Albuminuria remission rates
Rate of remission from macro to microalbuminuria and from micro to normoalbuminuria.

Full Information

First Posted
April 8, 2010
Last Updated
March 29, 2016
Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborators
Mario Negri Institute for Pharmacological Research
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1. Study Identification

Unique Protocol Identification Number
NCT01109212
Brief Title
The Effects of Bindarit in Diabetic Nephropathy
Official Title
The Effects of the Association Bindarit + Irbesartan Versus Irbesartan Alone on Albuminuria on Patients With Diabetic Nephropathy. Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborators
Mario Negri Institute for Pharmacological Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Type 2-Diabetic Nephrophaty, bindarit, albuminuria, MCP-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bindarit
Arm Type
Experimental
Arm Description
Patients treated with bindarit 2x300 mg bid plus irbesartan 2x150 mg once a day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients treated with placebo 2 tablets bid plus irbesartan 2x150 mg once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Bindarit
Other Intervention Name(s)
AF2838
Intervention Description
dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks
Primary Outcome Measure Information:
Title
Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen.
Description
Relative change (per cent change) in Urinary Albumin Excretion (UAE) from the baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen.
Description
Relative change (per cent change) in Urinary MCP-1 levels from the baseline.
Time Frame
12 weeks
Title
Serum lipids
Description
Relative change (per cent change) in total cholesterol, cholesterol HDL, triglycerides, apolipoprotein-A, apolipoprotein-B from the baseline.
Time Frame
12 weeks
Title
Safety and tolerability of bindarit in association of irbesartan.
Description
Changes in anthropometrics, laboratory parameters and vital signs from the baseline. Number of adverse events.
Time Frame
12 weeks
Title
Albuminuria remission rates
Description
Rate of remission from macro to microalbuminuria and from micro to normoalbuminuria.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Remuzzi, PhD
Organizational Affiliation
Mario Negri Institute for Pharmacological Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mario Negri Institute for Pharmacological Research- Clinical Research Center for Rare Diseases
City
Ranica
State/Province
Bergamo
ZIP/Postal Code
24020
Country
Italy
Facility Name
Azienda Ospedaliera di Treviglio-Caravaggio - Unità Operativa Malattie Metaboliche e Diabetologia
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Facility Name
Azienda Ospedaliera OO.RR. Bergamo - Unità Operativa Diabetologia
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
IRCCS Fondazione Centro S. Raffaele del Monte Tabor- Unità Operativa Medicina Generale
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ist. Patologia Medica e metodologia Clinica - Università di Sassari
City
Sassari
ZIP/Postal Code
7100
Country
Italy
Facility Name
University Medical Center Dpt Endocrinology Diabetes and Metabolic Diseases- Diabetology Unit
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Links:
URL
http://www.angelinipharma.com
Description
Sponsor's website

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The Effects of Bindarit in Diabetic Nephropathy

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