Bosentan Use in Patients With Diabetic Nephropathy
Information source: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: bosentan (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Centre hospitalier de l'Université de Montréal (CHUM) Official(s) and/or principal investigator(s): Maryse Courteau, MD, Principal Investigator, Affiliation: CHUM
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 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.
Clinical Details
Official title: Effect of Bosentan on Systemic and Renal Inflammatory Markers in Patients With Diabetic Nephropathy on Angiotensin II Receptor Blockers
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: change from baseline to week 16 in renal inflammation. The following urinary inflammatory/oxidative stress parameters will be measured: - TNF
Secondary outcome: change from baseline to week 16 in renal functioning. The following renal function parameter will be measured: - 24h UAE;
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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;
Locations and Contacts
CHUM, Montreal, Quebec H2L 4M1, Canada
Additional Information
Starting date: January 2009
Last updated: June 14, 2010
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