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
2 other identifiers
interventional
100
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2007
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 23, 2010
CompletedMarch 30, 2016
March 1, 2016
1.7 years
April 8, 2010
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen.
Relative change (per cent change) in Urinary Albumin Excretion (UAE) from the baseline
12 weeks
Secondary Outcomes (4)
Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen.
12 weeks
Serum lipids
12 weeks
Safety and tolerability of bindarit in association of irbesartan.
12 weeks
Albuminuria remission rates
12 weeks
Study Arms (2)
Bindarit
EXPERIMENTALPatients treated with bindarit 2x300 mg bid plus irbesartan 2x150 mg once a day for 12 weeks
Placebo
PLACEBO COMPARATORpatients treated with placebo 2 tablets bid plus irbesartan 2x150 mg once a day for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Azienda Ospedaliera OO.RR. Bergamo - Unità Operativa Diabetologia
Bergamo, Bergamo, 24128, Italy
The Mario Negri Institute for Pharmacological Research- Clinical Research Center for Rare Diseases
Ranica, Bergamo, 24020, Italy
Azienda Ospedaliera di Treviglio-Caravaggio - Unità Operativa Malattie Metaboliche e Diabetologia
Treviglio, Bergamo, 24047, Italy
IRCCS Fondazione Centro S. Raffaele del Monte Tabor- Unità Operativa Medicina Generale
Milan, Milano, 20132, Italy
Ist. Patologia Medica e metodologia Clinica - Università di Sassari
Sassari, Sassari, 7100, Italy
University Medical Center Dpt Endocrinology Diabetes and Metabolic Diseases- Diabetology Unit
Ljubljana, Ljubljana, 1000, Slovenia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Remuzzi, PhD
Mario Negri Institute for Pharmacological Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 23, 2010
Study Start
March 1, 2007
Primary Completion
November 1, 2008
Study Completion
December 1, 2008
Last Updated
March 30, 2016
Record last verified: 2016-03