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Bosentan Use in Patients With Diabetic Nephropathy

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Terminated
CT.gov ID
NCT00638131
Collaborator
Actelion (Industry)
1
Enrollment
1
Location
2
Arms
17
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Bosentan on Systemic and Renal Inflammatory Markers in Patients With Diabetic Nephropathy on Angiotensin II Receptor Blockers
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Bosentan 62.5mg bid x4 weeks; up-titrated to 125mg bid x12 weeks;

Drug: bosentan
62.5mg bid x4 weeks, up-titrate to 125mg bid x12 weeks
Other Names:
  • Tracleer

    		•
    Placebo Comparator: 2

    placebo given bid same as experimental arm;

    Drug: bosentan
    62.5mg bid x4 weeks, up-titrate to 125mg bid x12 weeks
    Other Names:
  • Tracleer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change from baseline to week 16 in renal inflammation. The following urinary inflammatory/oxidative stress parameters will be measured: - TNF [16 weeks]

    Secondary Outcome Measures

    1. change from baseline to week 16 in renal functioning. The following renal function parameter will be measured: - 24h UAE; [16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHUM Montreal Quebec Canada H2L 4M1

    Sponsors and Collaborators

    • Centre hospitalier de l'Université de Montréal (CHUM)
    • Actelion

    Investigators

    • Principal Investigator: Maryse Courteau, MD, CHUM

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre hospitalier de l'Université de Montréal (CHUM)
    ClinicalTrials.gov Identifier:
    NCT00638131
    Other Study ID Numbers:
    • BOS-ND-2007
    First Posted:
    Mar 18, 2008
    Last Update Posted:
    Jul 24, 2020
    Last Verified:
    Jun 1, 2010
    Additional relevant MeSH terms:
    Diabetic Nephropathies
    Bosentan

    Study Results

    No Results Posted as of Jul 24, 2020