Status:
TERMINATED
Bosentan Use in Patients With Diabetic Nephropathy
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Actelion
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00638131
Start Date
January 1 2009
End Date
June 1 2010
Last Update
July 24 2020
Active Locations (1)
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1
CHUM
Montreal, Quebec, Canada, H2L 4M1