An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)

Chronic Kidney Diseases Clinical Trial

— EAGLE  

Official title:

An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03749447
• Other study ID #: 402-C-1803
• Secondary ID: 2018-003253-24
• Status: Terminated
• Phase: Phase 3
• Start date: March 8, 2019
• Est. completion date: August 23, 2023

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 270
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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:

1. 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);

2. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable;

3. 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.

Related Conditions & MeSH terms

• Alport Syndrome
• Autosomal Dominant Polycystic Kidney
• Chronic Kidney Diseases
• Kidney Diseases
• Nephritis, Hereditary
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant
• Renal Insufficiency, Chronic

Intervention

Drug:
• Bardoxolone methyl
Bardoxolone methyl capsules

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	John Hunter Hospital	New Lambton	New South Wales
Australia	The Royal Melbourne Hospital	Parkville
Australia	Melbourne Renal Research Group	Reservoir	Victoria
France	Chu Grenoble Alpes	Grenoble
France	Hopital Necker, Universite Paris Descartes	Paris
Japan	Juntendo University Hospital	Bunkyo-Ku	Tokyo
Japan	Jutendo University Hospital	Bunkyo-Ku	Tokyo
Japan	Tokyo Metropolitan Children's Medical Center	Fuchu	Tokyo
Japan	St Marianna University Hospital	Kawasaki	Kanagawa
Japan	Toranomon Hospital Kajigaya	Kawasaki	Kanagawa
Japan	Kobe University Hospital	Kobe City	Hyogo
Japan	Toranomon Hospital	Minato-Ku	Tokyo
Japan	Japanese Red Cross Nagoya Daini Hospital	Nagoya-shi	Aichi
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital	Osaka
Japan	Kitano Hospital	Osaka-shi	Osaka
Japan	Saga University Hospital	Saga-shi	Saga
Japan	Saitama Children's Medical Center	Saitama-shi	Saitama
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	JCHO Sendai Hospital	Sendai-shi	Miyagi
Japan	Tokyo Women's Medical University Hospital	Shinjuku-Ku	Tokyo
Japan	Osaka University Hospital	Suita	Osaka
Puerto Rico	Puerto Rico Clinical and Translational Research Consortium (PRCTRC)	Rio Piedras
Spain	Fundacio Puigvert	Barcelona	Cataluna
Spain	Hospital Virgen de la Arrixaca	El Palmar	Murcia
United States	University of Michigan	Ann Arbor	Michigan
United States	Arlington Nephrology	Arlington	Texas
United States	Western Nephrology	Arvada	Colorado
United States	Mountain Kidney & Hypertension Associates	Asheville	North Carolina
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Center	Aurora	Colorado
United States	Research Management, Inc.	Austin	Texas
United States	The Johns Hopkins University	Baltimore	Maryland
United States	Renal Associates of Baton Rouge	Baton Rouge	Louisiana
United States	Northeast Clinical Research Center	Bethlehem	Pennsylvania
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Tufts Medical Center - Division of Nephrology	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Boise Kidney & Hypertension, PLLC	Caldwell	Idaho
United States	North Carolina Nephrology	Cary	North Carolina
United States	Metrolina Nephrology Associates	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Columbia Nephrology Associates, PA	Columbia	South Carolina
United States	Remington-Davis Clinical Research	Columbus	Ohio
United States	Renal Disease Research Institute	Dallas	Texas
United States	Colorado Kidney Care, PC	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Nephrology Research NorthShore University Health System	Evanston	Illinois
United States	Nephrology Associates of Northern Virginia, Inc.	Fairfax	Virginia
United States	Metrolina Nephrology Associates	Gastonia	North Carolina
United States	Arizona Kidney Disease and Hypertension Research Services, PLLC	Glendale	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	DaVita Med Center	Houston	Texas
United States	Southwest Houston Research	Houston	Texas
United States	Apogee Clinical Research	Huntsville	Alabama
United States	Nephrology Center, PC	Kalamazoo	Michigan
United States	Children's Mercy Hospital and Clinics	Kansas City	Missouri
United States	Clinical Research Consultants, LLC	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	California Institute Renal Research	La Mesa	California
United States	KSOSN	Las Vegas	Nevada
United States	South Florida Research Institute	Lauderdale Lakes	Florida
United States	Academic Medical Research Institute	Los Angeles	California
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Boise Kidney & Hypertension, PLLC	Meridian	Idaho
United States	Centricity Research Phoenix Multispecialty	Mesa	Arizona
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	South Carolina Nephrology & Hypertension Center, Inc	Orangeburg	South Carolina
United States	Innovation Medical Research, Inc.	Palmetto Bay	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Apex Research of Riverside	Riverside	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Clinical Advancement Center	San Antonio	Texas
United States	Rady Children's Hospital - San Diego	San Diego	California
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	Northwest Louisiana Nephrology	Shreveport	Louisiana
United States	USF Health South Tampa Center	Tampa	Florida
United States	Milwaukee Nephrologists, SC	Wauwatosa	Wisconsin
United States	Florida Premier Research Institute, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen

Countries where clinical trial is conducted

United States,  Australia,  France,  Japan,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)