| Trial ID: | L1108 |
| Source ID: | NCT01351675
|
| Associated Drug: |
Placebo
|
| Title: |
Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes
|
| Acronym: |
BEACON
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency, Chronic|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Placebo|DRUG: Bardoxolone Methyl: 20 mg
|
| Outcome Measures: |
Primary: Time-to-first event of the composite endpoint, Time-to-first event of the composite endpoint consisting of: * ESRD (need for chronic dialysis or renal transplantation) * Cardiovascular death, Approximately 24 months | Secondary: Rate of change in estimated glomerular filtration rate (eGFR) over the duration of the study, Approximately 24 months|Time to first hospitalization for heart failure, Approximately 24 months|Time to first event in the composite cardiorenal endpoint, Time-to-first event in the composite cardiorenal endpoint defined as: * Cardiovascular death * Non-fatal myocardial infarction * Non-fatal stroke * Hospitalization for heart failure, Approximately 24 months|Frequency, intensity, and relationship to study drug of adverse events and serious adverse events, as well as clinical and laboratory test abnormalities., Approximately 24 months
|
| Sponsor/Collaborators: |
Sponsor: Reata, a wholly owned subsidiary of Biogen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
2185
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-06-30
|
| Completion Date: |
2012-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-02
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01351675
|
