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The Effects of Bindarit in Diabetic Nephropathy

This study has been completed.
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by:
Aziende Chimiche Riunite Angelini Francesco S.p.A
ClinicalTrials.gov Identifier:
NCT01109212
First received: April 8, 2010
Last updated: April 22, 2010
Last verified: April 2010

April 8, 2010
April 22, 2010
March 2007
November 2008   (final data collection date for primary outcome measure)
Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Relative change (per cent change) in Urinary Albumin Excretion (UAE) from the baseline
Same as current
Complete list of historical versions of study NCT01109212 on ClinicalTrials.gov Archive Site
  • Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Relative change (per cent change) in Urinary MCP-1 levels from the baseline.
  • Serum lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Changes in anthropometrics, laboratory parameters and vital signs from the baseline. Number of adverse events.
  • Albuminuria remission rates [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Rate of remission from macro to microalbuminuria and from micro to normoalbuminuria.
Same as current
Not Provided
Not Provided
 
The Effects of Bindarit in Diabetic Nephropathy
The Effects of the Association Bindarit + Irbesartan Versus Irbesartan Alone on Albuminuria on Patients With Diabetic Nephropathy. Placebo-controlled Study

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Nephropathy
  • Drug: Bindarit
    dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks
    Other Name: AF2838
  • Drug: Placebo
    dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks
    Other Name: Placebo
  • Experimental: Bindarit
    Patients treated with bindarit 2x300 mg bid plus irbesartan 2x150 mg once a day for 12 weeks
    Intervention: Drug: Bindarit
  • Placebo Comparator: Placebo
    patients treated with placebo 2 tablets bid plus irbesartan 2x150 mg once a day for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Slovenia
 
NCT01109212
004SC06084, 2006-006191-38
No
Aziende Chimiche Riunite Angelini Francesco S.p.A, Research Center S.Palomba-Pomezia New Products Clinical Development Department
Aziende Chimiche Riunite Angelini Francesco S.p.A
Mario Negri Institute for Pharmacological Research
Principal Investigator: Giuseppe Remuzzi, PhD Mario Negri Institute for Pharmacological Research
Aziende Chimiche Riunite Angelini Francesco S.p.A
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP