An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
- Conditions
- Alport SyndromeChronic Kidney DiseasesAutosomal Dominant Polycystic Kidney
- Interventions
- Registration Number
- NCT03749447
- Lead Sponsor
- Reata, a wholly owned subsidiary of Biogen
- Brief Summary
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.
- Detailed Description
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 270
-
Patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial.
-
Meets the following eligibility criteria based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable:
- Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with eGFR <20 ml/min/1.73m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline > 1.0 ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not be eligible);
- BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable;
- No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable.
-
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
-
Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.
- Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication;
- Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
- Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while screening, taking study drug and 30 days after the last study drug dose;
- Women who are pregnant or breastfeeding;
- Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
- Known hypersensitivity to any component of the study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bardoxolone methyl Bardoxolone methyl Adult participants received bardoxolone methyl capsules, once daily (QD) at a starting dose of 5 milligrams (mg), followed by dose- escalation to 10 mg at Week 2 (Day 14 ± 3), and to 20 mg at Week 4 (Day 28 ± 3). Based on the eligibility UACR \>300 milligrams per gram (mg/g), the dose was increased to 30 mg starting from Week 6 (Day 42 ± 3) until the end of the study. Participants under 18 years of age received bardoxolone methyl capsules at a starting dose of 5 mg every other day during the first week and QD during the second week of the study, followed by dose-escalation to 10 mg at Week 2 and to 20 mg at Week 4. Based on the eligibility UACR \>300 mg/g, the dose was increased to 30 mg starting from Week 6 until the end of the study.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (85)
Chu Grenoble Alpes
🇫🇷Grenoble, France
Hopital Necker, Universite Paris Descartes
🇫🇷Paris, France
John Hunter Hospital
🇦🇺New Lambton, New South Wales, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Kobe University Hospital
🇯🇵Kobe City, Hyogo, Japan
Saitama Children's Medical Center
🇯🇵Saitama-shi, Saitama, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
Fundacio Puigvert
🇪🇸Barcelona, Cataluna, Spain
Toranomon Hospital Kajigaya
🇯🇵Kawasaki, Kanagawa, Japan
JCHO Sendai Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Tufts Medical Center - Division of Nephrology
🇺🇸Boston, Massachusetts, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Southwest Houston Research
🇺🇸Houston, Texas, United States
Apogee Clinical Research
🇺🇸Huntsville, Alabama, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
California Institute Renal Research
🇺🇸La Mesa, California, United States
Academic Medical Research Institute
🇺🇸Los Angeles, California, United States
Apex Research of Riverside
🇺🇸Riverside, California, United States
Florida Premier Research Institute, LLC
🇺🇸Winter Park, Florida, United States
South Florida Research Institute
🇺🇸Lauderdale Lakes, Florida, United States
Innovation Medical Research, Inc.
🇺🇸Palmetto Bay, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Nephrology Research NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Northwest Louisiana Nephrology
🇺🇸Shreveport, Louisiana, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Mountain Kidney & Hypertension Associates
🇺🇸Asheville, North Carolina, United States
North Carolina Nephrology
🇺🇸Cary, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Metrolina Nephrology Associates
🇺🇸Gastonia, North Carolina, United States
Remington-Davis Clinical Research
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Northeast Clinical Research Center
🇺🇸Bethlehem, Pennsylvania, United States
Arlington Nephrology
🇺🇸Arlington, Texas, United States
Renal Disease Research Institute
🇺🇸Dallas, Texas, United States
DaVita Med Center
🇺🇸Houston, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Nephrology Associates of Northern Virginia, Inc.
🇺🇸Fairfax, Virginia, United States
KSOSN
🇺🇸Las Vegas, Nevada, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
Western Nephrology
🇺🇸Arvada, Colorado, United States
Colorado Kidney Care, PC
🇺🇸Denver, Colorado, United States
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
🇵🇷Rio Piedras, Puerto Rico
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
St Marianna University Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Saga University Hospital
🇯🇵Saga-shi, Saga, Japan
Hospital Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Centricity Research Phoenix Multispecialty
🇺🇸Mesa, Arizona, United States
Arizona Kidney Disease and Hypertension Research Services, PLLC
🇺🇸Glendale, Arizona, United States
Jutendo University Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Columbia Nephrology Associates, PA
🇺🇸Columbia, South Carolina, United States
Milwaukee Nephrologists, SC
🇺🇸Wauwatosa, Wisconsin, United States
Nephrology Center, PC
🇺🇸Kalamazoo, Michigan, United States
Kitano Hospital
🇯🇵Osaka-shi, Osaka, Japan
Tokyo Metropolitan Children's Medical Center
🇯🇵Fuchū, Tokyo, Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
🇯🇵Osaka, Japan
Renal Associates of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Boise Kidney & Hypertension, PLLC
🇺🇸Meridian, Idaho, United States
Melbourne Renal Research Group
🇦🇺Reservoir, Victoria, Australia
Japanese Red Cross Nagoya Daini Hospital
🇯🇵Nagoya-shi, Aichi, Japan
South Carolina Nephrology & Hypertension Center, Inc
🇺🇸Orangeburg, South Carolina, United States
Toranomon Hospital
🇯🇵Minato-Ku, Tokyo, Japan
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California San Francisco - Children's Renal Center
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Clinical Advancement Center
🇺🇸San Antonio, Texas, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado Anschutz Medical Center
🇺🇸Aurora, Colorado, United States
USF Health South Tampa Center
🇺🇸Tampa, Florida, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
The Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Research Management, Inc.
🇺🇸Austin, Texas, United States
Children's Mercy Hospital and Clinics
🇺🇸Kansas City, Missouri, United States
Clinical Research Consultants, LLC
🇺🇸Kansas City, Missouri, United States
Juntendo University Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States