Diabetic NephropathyPhase 2NCT01109212
The Effects of Bindarit in Diabetic Nephropathy
A Phase 2 study testing Bindarit in people with Diabetic Nephropathy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Bindarit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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];
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Italy5 sites
Azienda Ospedaliera OO.RR. Bergamo - Unità Operativa Diabetologia
Bergamo, Bergamo, 24128
IRCCS Fondazione Centro S. Raffaele del Monte Tabor- Unità Operativa Medicina Generale
Milan, Milano, 20132
The Mario Negri Institute for Pharmacological Research- Clinical Research Center for Rare Diseases
Ranica, Bergamo, 24020
Ist. Patologia Medica e metodologia Clinica - Università di Sassari
Sassari, Sassari, 7100
Azienda Ospedaliera di Treviglio-Caravaggio - Unità Operativa Malattie Metaboliche e Diabetologia
Treviglio, Bergamo, 24047
Slovenia1 site
University Medical Center Dpt Endocrinology Diabetes and Metabolic Diseases- Diabetology Unit
Ljubljana, Ljubljana, 1000
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diabetic Nephropathy
- Being tested
- Bindarit, Placebo
- Keywords
- Type 2-Diabetic Nephrophaty, bindarit, albuminuria, MCP-1
- Medical subject headings
- Diabetic Nephropathies, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BindaritDrug
Also called AF2838
dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks
PlaceboDrug
dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bindarit | Experimental | Patients treated with bindarit 2x300 mg bid plus irbesartan 2x150 mg once a day for 12 weeks Receives: Drug: Bindarit |
| Placebo | Placebo comparator | patients treated with placebo 2 tablets bid plus irbesartan 2x150 mg once a day for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen.
Relative change (per cent change) in Urinary Albumin Excretion (UAE) from the baseline
Measured: 12 weeks
Secondary outcomes (4)
Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen.
Relative change (per cent change) in Urinary MCP-1 levels from the baseline.
Measured: 12 weeks
Serum lipids
Relative change (per cent change) in total cholesterol, cholesterol HDL, triglycerides, apolipoprotein-A, apolipoprotein-B from the baseline.
Measured: 12 weeks
Safety and tolerability of bindarit in association of irbesartan.
Changes in anthropometrics, laboratory parameters and vital signs from the baseline. Number of adverse events.
Measured: 12 weeks
Albuminuria remission rates
Rate of remission from macro to microalbuminuria and from micro to normoalbuminuria.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startMar 2007
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mario Negri Institute for Pharmacological Research
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, PhD, Principal investigator, Mario Negri Institute for Pharmacological Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109212
- Sponsor's protocol ID
- 004SC06084
- Other IDs
- 2006-006191-38
- Status last verified
- Mar 2016
- First submitted
- 8 Apr 2010
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Association Bindarit + Irbesartan Versus Irbesartan Alone on Albuminuria on Patients With Diabetic Nephropathy. Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01109212
- Acronym / sponsor ID
- 004SC06084
- Conditions
- Diabetic Nephropathy
- Keywords
- Type 2-Diabetic Nephrophaty, bindarit, albuminuria, MCP-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Mario Negri Institute for Pharmacological Research
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bindarit | Experimental | Drug: BindaritPatients treated with bindarit 2x300 mg bid plus irbesartan 2x150 mg once a day for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebopatients treated with placebo 2 tablets bid plus irbesartan 2x150 mg once a day for 12 weeks |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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];
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BindaritAlso: AF2838dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks | Drug | Bindarit |
| Placebodosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Urinary Monocyte Chemoattractant protein (MCP-1/CCL2)(pg/ml) levels in the overnight urine specimen.
Time frame: 12 weeks
Serum lipids
Time frame: 12 weeks
Safety and tolerability of bindarit in association of irbesartan.
Time frame: 12 weeks
Albuminuria remission rates
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Remuzzi, PhD principal investigator
Mario Negri Institute for Pharmacological Research
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bindarit in people with Diabetic Nephropathy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Albumin Excretion (µg/min) levels in the overnight urine specimen. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.