The Effects of Bindarit in Diabetic Nephropathy
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109212
|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|