The Effects of Bindarit in Diabetic Nephropathy
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|ClinicalTrials.gov Identifier: NCT01109212|
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : March 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy||Drug: Bindarit Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of the Association Bindarit + Irbesartan Versus Irbesartan Alone on Albuminuria on Patients With Diabetic Nephropathy. Placebo-controlled Study|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2008|
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
- Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen. [ Time Frame: 12 weeks ]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 ]Relative change (per cent change) in Urinary MCP-1 levels from the baseline.
- Serum lipids [ Time Frame: 12 weeks ]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 ]Changes in anthropometrics, laboratory parameters and vital signs from the baseline. Number of adverse events.
- Albuminuria remission rates [ Time Frame: 12 weeks ]Rate of remission from macro to microalbuminuria and from micro to normoalbuminuria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|