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Bosentan Use in Patients With Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT00638131
Recruitment Status : Terminated (problem of recruitment)
First Posted : March 18, 2008
Last Update Posted : June 15, 2010
Sponsor:
Collaborator:
Information provided by:

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
Type 2 Diabetes Drug: bosentan Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
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 : January 2009
Estimated Primary Completion Date : March 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bosentan
U.S. FDA Resources

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 Name: 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 Name: 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 [ Time Frame: 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; [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638131


Locations
Canada, Quebec
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
More Information

Responsible Party: Dr. Geneviève Renier, CHUM
ClinicalTrials.gov Identifier: NCT00638131     History of Changes
Other Study ID Numbers: BOS-ND-2007
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bosentan
Angiotensin Receptor Antagonists
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action