- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00638131
Bosentan Use in Patients With Diabetic Nephropathy
July 22, 2020 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
Effect of Bosentan on Systemic and Renal Inflammatory Markers in Patients With Diabetic Nephropathy on Angiotensin II Receptor Blockers
There is little doubt of the necessity for further improvement in the prevention and therapy of end-stage renal disease.
Despite the success of ARB in treating diabetic nephropathy, not all patients obtain satisfactory control of blood pressure, albuminuria and decline in renal function.
Experimental data have provided us with a rationale for the potential added benefits of ET receptor blockade to the AII inhibition in diabetic renal protection.
Considering the nephroprotective effect of bosentan in diabetic rats, clinical studies are warranted to assess whether ET receptor antagonism has additive renoprotective effects on top of AII inhibition.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2L 4M1
- CHUM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women ≥ 18 years of age with a body weight of ≥ 40 kg;
- For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using intrauterine devices (IUDs);
- Patients diagnosed Type 2 diabetes with overt nephropathy (urinary albumin excretion ≥ 300mg/24h);
- Patients on current treatment with angiotensin II receptor blockers for ≥ 3 months;
- Patients stable for at least 3 months prior to screening (no change in medications for diabetic nephropathy);
- Provide written informed consent;
Exclusion Criteria:
- Patients with a history of pulmonary chronic obstructive disease, cardiac failure or coronary artery disease;
- Patients with documented cancers, acute infections or chronic inflammatory diseases;
- Patients who are pregnant or breast-feeding;
- Patients with known hepatic disorders or AST and ∕or ALT upper than normal limit;
- Patients with hemoglobin or hematocrit that is ≥ 30% below the normal range (patients with secondary polycythemia are permitted);
- Patients with systolic blood pressure < 110mm Hg;
- Patients with plasmatic albumin level < 30g/L;
- Patients with a documented creatinine clearance ≤ 60ml/min;
- Patients on anticoagulants or anti-inflammatory drugs, including cyclooxygenase inhibitors, AINS, prednisone and immunosuppressive drugs, platelet aggregation inhibitors, except low dose aspirin, ACE inhibitors, antidiabetic agents (rosiglitazone, pioglitazone) and antioxidants (vitamin E)(except statins or low-dose aspirin ≤ 80mg/day);
- Patients on treatment or planned treatment with another investigational drug;
- Patients who are receiving an endothelin receptor antagonist, phosphodiesterase type 5 inhibitor, or with a prostanoid (excluding acute administration during a catheterization procedure to test vascular reactivity) within 2 months of inclusion;
- Patients who are receiving calcineurin-inhibitors (i.e., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) at inclusion or are expected to receive any of these drugs during the study;
- Patients with a known hypersensitivity to bosentan or any of the excipients;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Bosentan 62.5mg bid x4 weeks; up-titrated to 125mg bid x12 weeks;
|
62.5mg bid x4 weeks, up-titrate to 125mg bid x12 weeks
Other Names:
|
Placebo Comparator: 2
placebo given bid same as experimental arm;
|
62.5mg bid x4 weeks, up-titrate to 125mg bid x12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline to week 16 in renal inflammation. The following urinary inflammatory/oxidative stress parameters will be measured: - TNF
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline to week 16 in renal functioning. The following renal function parameter will be measured: - 24h UAE;
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Maryse Courteau, MD, CHUM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
March 12, 2008
First Submitted That Met QC Criteria
March 17, 2008
First Posted (Estimate)
March 18, 2008
Study Record Updates
Last Update Posted (Actual)
July 24, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOS-ND-2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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