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| Sponsor: | Reata Pharmaceuticals, Inc. |
|---|---|
| Information provided by (Responsible Party): | Reata Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01351675 |
Purpose
This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Insufficiency, Chronic Diabetes Mellitus, Type 2 |
Drug: Placebo Drug: Bardoxolone Methyl: 20 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON) |
Time-to-first event of the composite endpoint consisting of:
Time-to-first event in the composite cardiorenal endpoint defined as:
| Estimated Enrollment: | 2000 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Oral, once daily
|
| Experimental: Bardoxolone Methyl |
Drug: Bardoxolone Methyl: 20 mg
20 mg, oral, once daily
Other Name: RTA-402
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 303 Study Locations
More Information
| Responsible Party: | Reata Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01351675 History of Changes |
| Other Study ID Numbers: | 402-C-0903 |
| Study First Received: | December 3, 2010 |
| Last Updated: | May 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic kidney disease Type 2 diabetes Diabetic nephropathy |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic |
Renal Insufficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases |