Clinical Trial Details
| Trial ID: | L1304 |
| Source ID: | NCT01053936 |
| Associated Drug: | Bardoxolone Methyl (Amorphous Dispersion) |
| Title: | Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Renal Insufficiency, Chronic|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Bardoxolone methyl (amorphous dispersion) |
| Outcome Measures: | Primary: To assess a trend in mean change from baseline to Day 29 in eGFR (as estimated by the 4-component MDRD formula) with increasing doses of bardoxolone methyl (amorphous dispersion) in patients with Type 2 diabetes and CKD (eGFR 15-45 mL/min/1.73m2)., 29 Days | Secondary: To evaluate the safety and tolerability of bardoxolone methyl (amorphous dispersion) after 28 and 84 days of administration., 85 days|To assess a trend in mean change from baseline to Day 85 in eGFR (as estimated by the 4-component MDRD formula with increasing doses of bardoxolone methyl (amorphous dispersion) in patients with Type 2 diabetes and CKD (eGFR 15-45 mL/min/1.73m2), 85 days |
| Sponsor/Collaborators: | Sponsor: Reata, a wholly owned subsidiary of Biogen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 129 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2010-01-31 |
| Completion Date: | 2011-02-28 |
| Results First Posted: | |
| Last Update Posted: | 2024-02-02 |
| Locations: | Montgomery, Alabama, 36106, United States|Phoenix, Arizona, 85012, United States|Tempe, Arizona, 85284, United States|La Mesa, California, 91942, United States|Riverside, California, 92505, United States|San Dimas, California, 91773, United States|Washington, District of Columbia, 20036, United States|Brandon, Florida, 33511, United States|Port Charlotte, Florida, 33952, United States|West Palm Beach, Florida, 33401, United States|Augusta, Georgia, 30901, United States|Canton, Georgia, 30114, United States|Chicago, Illinois, 60616, United States|Peoria, Illinois, 61603, United States|Brooklyn Center, Minnesota, 55430, United States|Morehead City, North Carolina, 28557, United States|Winston-Salem, North Carolina, 27103, United States|Pittsburgh, Pennsylvania, 15224, United States|Providence, Rhode Island, 02904, United States|Chattanooga, Tennessee, 37304, United States|Corpus Christi, Texas, 78404, United States|Dallas, Texas, 75390, United States|Greenville, Texas, 75402, United States|Houston, Texas, 77099, United States|San Antonio, Texas, 78215, United States|Federal Way, Washington, 98003, United States |
| URL: | https://clinicaltrials.gov/show/NCT01053936 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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