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Clinical Trial Details

Trial ID: L0597
Source ID: NCT03749447
Associated Drug: Bardoxolone Methyl
Title: An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
Acronym: EAGLE
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03749447/results
Conditions: Chronic Kidney Diseases|Alport Syndrome|Autosomal Dominant Polycystic Kidney
Interventions: DRUG: Bardoxolone methyl
Outcome Measures: Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. AEs and SAEs that occurred within 30 days after the last dose were considered treatment-emergent. The study follow-up assessment was collected within 14 to 35 days after the last dose., From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years) |
Sponsor/Collaborators: Sponsor: Reata, a wholly owned subsidiary of Biogen
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 270
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-03-08
Completion Date: 2023-08-23
Results First Posted: 2024-03-19
Last Update Posted: 2024-03-19
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|Apogee Clinical Research, Huntsville, Alabama, 35805, United States|Arizona Kidney Disease and Hypertension Research Services, PLLC, Glendale, Arizona, 85306, United States|Centricity Research Phoenix Multispecialty, Mesa, Arizona, 85206, United States|California Institute Renal Research, La Mesa, California, 91942, United States|Academic Medical Research Institute, Los Angeles, California, 90022, United States|David Geffen School of Medicine at UCLA, Los Angeles, California, 90095, United States|Apex Research of Riverside, Riverside, California, 92505, United States|Rady Children's Hospital - San Diego, San Diego, California, 92123, United States|University of California San Francisco - Children's Renal Center, San Francisco, California, 94143, United States|University of California, San Francisco, San Francisco, California, 94143, United States|Western Nephrology, Arvada, Colorado, 80002, United States|University of Colorado Anschutz Medical Center, Aurora, Colorado, 80045, United States|Colorado Kidney Care, PC, Denver, Colorado, 80230, United States|South Florida Research Institute, Lauderdale Lakes, Florida, 33313, United States|Innovation Medical Research, Inc., Palmetto Bay, Florida, 33157, United States|USF Health South Tampa Center, Tampa, Florida, 33606, United States|Florida Premier Research Institute, LLC, Winter Park, Florida, 32789, United States|Emory University School of Medicine, Atlanta, Georgia, 30322, United States|Boise Kidney & Hypertension, PLLC, Caldwell, Idaho, 83605, United States|Boise Kidney & Hypertension, PLLC, Meridian, Idaho, 83642, United States|Northwestern University, Chicago, Illinois, 60611, United States|Nephrology Research NorthShore University Health System, Evanston, Illinois, 60201, United States|University of Kansas Medical Center, Kansas City, Kansas, 66224, United States|Renal Associates of Baton Rouge, Baton Rouge, Louisiana, 70808, United States|Northwest Louisiana Nephrology, Shreveport, Louisiana, 71101, United States|The Johns Hopkins University, Baltimore, Maryland, 21287, United States|Tufts Medical Center - Division of Nephrology, Boston, Massachusetts, 02110, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States|Nephrology Center, PC, Kalamazoo, Michigan, 49007, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Children's Mercy Hospital and Clinics, Kansas City, Missouri, 64108, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|KSOSN, Las Vegas, Nevada, 89128, United States|Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Columbia University Medical Center, New York, New York, 10032, United States|Mountain Kidney & Hypertension Associates, Asheville, North Carolina, 28801, United States|North Carolina Nephrology, Cary, North Carolina, 27511, United States|Metrolina Nephrology Associates, Charlotte, North Carolina, 28208, United States|Duke University Medical Center, Durham, North Carolina, 27701, United States|Metrolina Nephrology Associates, Gastonia, North Carolina, 28054, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Remington-Davis Clinical Research, Columbus, Ohio, 43215, United States|Oregon Health and Science University, Portland, Oregon, 97239, United States|Northeast Clinical Research Center, Bethlehem, Pennsylvania, 18017, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Columbia Nephrology Associates, PA, Columbia, South Carolina, 29203, United States|South Carolina Nephrology & Hypertension Center, Inc, Orangeburg, South Carolina, 29118, United States|Arlington Nephrology, Arlington, Texas, 76015, United States|Research Management, Inc., Austin, Texas, 78751, United States|Renal Disease Research Institute, Dallas, Texas, 75204, United States|DaVita Med Center, Houston, Texas, 77004, United States|Southwest Houston Research, Houston, Texas, 77099, United States|Clinical Advancement Center, San Antonio, Texas, 78215, United States|University of Vermont Medical Center, Burlington, Vermont, 05401, United States|Nephrology Associates of Northern Virginia, Inc., Fairfax, Virginia, 22033, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|Milwaukee Nephrologists, SC, Wauwatosa, Wisconsin, 53226, United States|John Hunter Hospital, New Lambton, New South Wales, 2305, Australia|Royal Brisbane and Women's Hospital, Herston, Queensland, 4029, Australia|Melbourne Renal Research Group, Reservoir, Victoria, 3073, Australia|The Royal Melbourne Hospital, Parkville, 3050, Australia|Chu Grenoble Alpes, Grenoble, 38043, France|Hopital Necker, Universite Paris Descartes, Paris, 75015, France|Japanese Red Cross Nagoya Daini Hospital, Nagoya-shi, Aichi, 466-8650, Japan|Hokkaido University Hospital, Sapporo, Hokkaido, 060-8648, Japan|Kobe University Hospital, Kobe City, Hyogo, 650-0017, Japan|Toranomon Hospital Kajigaya, Kawasaki, Kanagawa, 213-8587, Japan|St Marianna University Hospital, Kawasaki, Kanagawa, 216-8511, Japan|JCHO Sendai Hospital, Sendai-shi, Miyagi, 981-3281, Japan|Kitano Hospital, Osaka-shi, Osaka, 530-8480, Japan|Osaka University Hospital, Suita, Osaka, 565-8971, Japan|Saga University Hospital, Saga-shi, Saga, 849-8501, Japan|Saitama Children's Medical Center, Saitama-shi, Saitama, 330-8777, Japan|Juntendo University Hospital, Bunkyō-Ku, Tokyo, 113-8431, Japan|Jutendo University Hospital, Bunkyō-Ku, Tokyo, 113-8431, Japan|Tokyo Metropolitan Children's Medical Center, Fuchū, Tokyo, 183-8561, Japan|Toranomon Hospital, Minato-Ku, Tokyo, 105-8470, Japan|Tokyo Women's Medical University Hospital, Shinjuku-Ku, Tokyo, 162-8666, Japan|Niigata University Medical and Dental Hospital, Niigata, 951-8520, Japan|Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital, Osaka, 834-0021, Japan|Puerto Rico Clinical and Translational Research Consortium (PRCTRC), Rio Piedras, 00935, Puerto Rico|Fundacio Puigvert, Barcelona, Cataluna, 08025, Spain|Hospital Virgen de la Arrixaca, El Palmar, Murcia, 30120, Spain
URL: https://clinicaltrials.gov/show/NCT03749447

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress