Bosentan Use in Patients With Diabetic Nephropathy

NCT00638131 | Terminated Phase 3

• 1 other identifier: BOS-ND-2007
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  16 weeks

Secondary Outcomes (1)

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

  16 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Drug: bosentan

2

PLACEBO COMPARATOR

placebo given bid same as experimental arm;

Drug: bosentan

Interventions

bosentan DRUG

62.5mg bid x4 weeks, up-titrate to 125mg bid x12 weeks

Also known as: Tracleer

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 with a known hypersensitivity to bosentan or any of the excipients;

Sponsors & Collaborators

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

Study Sites (1)

CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Maryse Courteau, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 18, 2008
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 24, 2020

Record last verified: 2010-06

Locations

CA (1)