The Effects of Bindarit in Diabetic Nephropathy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of the Association Bindarit + Irbesartan Versus Irbesartan Alone on Albuminuria on Patients With Diabetic Nephropathy. Placebo-controlled Study|
- 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
- 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.
|Study Start Date:||March 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Patients treated with bindarit 2x300 mg bid plus irbesartan 2x150 mg once a day for 12 weeks
dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks
Other Name: AF2838
Placebo Comparator: Placebo
patients treated with placebo 2 tablets bid plus irbesartan 2x150 mg once a day for 12 weeks
dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks
Other Name: Placebo
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.
|The Mario Negri Institute for Pharmacological Research- Clinical Research Center for Rare Diseases|
|Ranica, Bergamo, Italy, 24020|
|Azienda Ospedaliera di Treviglio-Caravaggio - Unità Operativa Malattie Metaboliche e Diabetologia|
|Treviglio, Bergamo, Italy, 24047|
|Azienda Ospedaliera OO.RR. Bergamo - Unità Operativa Diabetologia|
|Bergamo, Italy, 24128|
|IRCCS Fondazione Centro S. Raffaele del Monte Tabor- Unità Operativa Medicina Generale|
|Milano, Italy, 20132|
|Ist. Patologia Medica e metodologia Clinica - Università di Sassari|
|Sassari, Italy, 7100|
|University Medical Center Dpt Endocrinology Diabetes and Metabolic Diseases- Diabetology Unit|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Giuseppe Remuzzi, PhD||Mario Negri Institute for Pharmacological Research|