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Clinical Trial Details

Trial ID: L0759
Source ID: NCT03366337
Associated Drug: Bardoxolone Methyl Capsules
Title: A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
Acronym: PHOENIX
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03366337/results
Conditions: IgA Nephropathy|CKD Associated With Type 1 Diabetes|Focal Segmental Glomerulosclerosis|Autosomal Dominant Polycystic Kidney
Interventions: DRUG: Bardoxolone methyl capsules
Outcome Measures: Primary: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12, To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function., 12 weeks after participant receives the first dose |
Sponsor/Collaborators: Sponsor: Reata, a wholly owned subsidiary of Biogen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 103
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-12-26
Completion Date: 2019-01-29
Results First Posted: 2022-01-18
Last Update Posted: 2024-02-05
Locations: University of Alabama Birmingham, Birmingham, Alabama, 35294, United States|Phoenician Centers for Research & Innovation (PCRI), Phoenix, Arizona, 85021, United States|University of California Los Angeles, Los Angeles, California, 90095, United States|Denver Nephrology, Denver, Colorado, 80230, United States|Gulfcoast Endocrine and Diabetes Center, Clearwater, Florida, 33756, United States|South Florida Research Institute, Lauderdale Lakes, Florida, 33313, United States|Coastal Nephrology Associates, Port Charlotte, Florida, 33952, United States|Kidney Care Augusta, Augusta, Georgia, 30909, United States|Boise Kidney & Hypertension, PLLC, Caldwell, Idaho, 83605, United States|Boise Kidney & Hypertension, PLLC, Meridian, Idaho, 83642, United States|Research By Design, Evergreen Park, Illinois, 60805, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|Four Rivers Clinical Research, Inc, Paducah, Kentucky, 42003, United States|Northwest Louisiana Nephrology, Shreveport, Louisiana, 71101, United States|Tufts Medical Center - Division of Nephrology Tufts Medical Center, Boston, Massachusetts, 02110, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Jacobi Medical Center, Bronx, New York, 10461, United States|Columbia University Medical Center - Nephrology, New York, New York, 10032, United States|Physician's East Endocrine Research, Greenville, North Carolina, 27834, United States|Remington-Davis Clinical Research, Columbus, Ohio, 43215, United States|Northeast Clinical Research Center, LLC, Bethlehem, Pennsylvania, 18017, United States|The Warren Alpert School of Brown University, Providence, Rhode Island, 02903, United States|Nephrology Associates, Chattanooga, Tennessee, 37404, United States|Research Management, Inc., Austin, Texas, 78751, United States|Renal Disease Research Intitute, Dallas, Texas, 75235, United States|Renal Associates, PA, San Antonio, Texas, 78215, United States|Advanced Clinical Research, West Jordan, Utah, 84088, United States|Mendez Center for Clinical Research LLC, Fairfax Station, Virginia, 22039, United States|Larry Stonesifer, M.D., Federal Way, Washington, 98003, United States
URL: https://clinicaltrials.gov/show/NCT03366337