An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) (EAGLE)
Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Bardoxolone methyl, CDDO-ME, RTA 402, Alport Syndrome, Autosomal Dominant Polycystic Kidney, ADPKD
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Alabama at Birmingham
- Apogee Clinical Research
- Arizona Kidney Disease and Hypertension Research Services, PLLC
- Centricity Research Phoenix Multispecialty
- California Institute Renal Research
- Academic Medical Research Institute
- David Geffen School of Medicine at UCLA
- Apex Research of Riverside
- Rady Children's Hospital - San Diego
- University of California San Francisco - Children's Renal Center
- University of California, San Francisco
- Western Nephrology
- University of Colorado Anschutz Medical Center
- Colorado Kidney Care, PC
- South Florida Research Institute
- Innovation Medical Research, Inc.
- USF Health South Tampa Center
- Florida Premier Research Institute, LLC
- Emory University School of Medicine
- Boise Kidney & Hypertension, PLLC
- Boise Kidney & Hypertension, PLLC
- Northwestern University
- Nephrology Research NorthShore University Health System
- University of Kansas Medical Center
- Renal Associates of Baton Rouge
- Northwest Louisiana Nephrology
- The Johns Hopkins University
- Tufts Medical Center - Division of Nephrology
- Tufts Medical Center
- University of Michigan
- Nephrology Center, PC
- Mayo Clinic
- Children's Mercy Hospital and Clinics
- Clinical Research Consultants, LLC
- Washington University School of Medicine
- KSOSN
- Hackensack University Medical Center
- Columbia University Medical Center
- Mountain Kidney & Hypertension Associates
- North Carolina Nephrology
- Metrolina Nephrology Associates
- Duke University Medical Center
- Metrolina Nephrology Associates
- Cleveland Clinic
- Remington-Davis Clinical Research
- Oregon Health and Science University
- Northeast Clinical Research Center
- Children's Hospital of Philadelphia
- UPMC Children's Hospital of Pittsburgh
- Columbia Nephrology Associates, PA
- South Carolina Nephrology & Hypertension Center, Inc
- Arlington Nephrology
- Research Management, Inc.
- Renal Disease Research Institute
- DaVita Med Center
- Southwest Houston Research
- Clinical Advancement Center
- University of Vermont Medical Center
- Nephrology Associates of Northern Virginia, Inc.
- Medical College of Wisconsin
- Milwaukee Nephrologists, SC
- John Hunter Hospital
- Royal Brisbane and Women's Hospital
- Melbourne Renal Research Group
- The Royal Melbourne Hospital
- Chu Grenoble Alpes
- Hopital Necker, Universite Paris Descartes
- Japanese Red Cross Nagoya Daini Hospital
- Hokkaido University Hospital
- Kobe University Hospital
- Toranomon Hospital Kajigaya
- St Marianna University Hospital
- JCHO Sendai Hospital
- Kitano Hospital
- Osaka University Hospital
- Saga University Hospital
- Saitama Children's Medical Center
- Juntendo University Hospital
- Jutendo University Hospital
- Tokyo Metropolitan Children's Medical Center
- Toranomon Hospital
- Tokyo Women's Medical University Hospital
- Niigata University Medical and Dental Hospital
- Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
- Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
- Fundacio Puigvert
- Hospital Virgen de la Arrixaca
Arms of the Study
Arm 1
Experimental
Bardoxolone methyl
The maximum dosage is determined by proteinuria status from the last on-treatment visit in the prior qualifying study or a screening visit, if necessary. Initial daily dose of bardoxolone methyl will dose-escalate at Week 2, Week 4, and Week 6. Patients under the age of 18 will start dosing with bardoxolone methyl capsules every other day during Week 1 and daily at Week 2. Patients will receive doses of bardoxolone methyl capsules in an escalating scheme from 5 mg up to no more than 30 mg.