Clinical trial NCT03749447: An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
Official title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Kidney Diseases
Alport Syndrome
Autosomal Dominant Polycystic Kidney
Keywords: Bardoxolone methyl
CDDO-ME
RTA 402
Alport Syndrome
Autosomal Dominant Polycystic Kidney
ADPKD
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 270
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Apogee Clinical Research
state: Alabama
city: Glendale
country: United States
facility: Arizona Kidney Disease and Hypertension Research Services, PLLC
state: Arizona
city: Mesa
country: United States
facility: Centricity Research Phoenix Multispecialty
state: Arizona
city: La Mesa
country: United States
facility: California Institute Renal Research
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital - San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco - Children's Renal Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Arvada
country: United States
facility: Western Nephrology
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Center
state: Colorado
city: Denver
country: United States
facility: Colorado Kidney Care, PC
state: Colorado
city: Lauderdale Lakes
country: United States
facility: South Florida Research Institute
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research, Inc.
state: Florida
city: Tampa
country: United States
facility: USF Health South Tampa Center
state: Florida
city: Winter Park
country: United States
facility: Florida Premier Research Institute, LLC
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Caldwell
country: United States
facility: Boise Kidney & Hypertension, PLLC
state: Idaho
city: Meridian
country: United States
facility: Boise Kidney & Hypertension, PLLC
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: Nephrology Research NorthShore University Health System
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baton Rouge
country: United States
facility: Renal Associates of Baton Rouge
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology
state: Louisiana
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center - Division of Nephrology
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: Nephrology Center, PC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital and Clinics
state: Missouri
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: KSOSN
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Asheville
country: United States
facility: Mountain Kidney & Hypertension Associates
state: North Carolina
city: Cary
country: United States
facility: North Carolina Nephrology
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Gastonia
country: United States
facility: Metrolina Nephrology Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis Clinical Research
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Nephrology Associates, PA
state: South Carolina
city: Orangeburg
country: United States
facility: South Carolina Nephrology & Hypertension Center, Inc
state: South Carolina
city: Arlington
country: United States
facility: Arlington Nephrology
state: Texas
city: Austin
country: United States
facility: Research Management, Inc.
state: Texas
city: Dallas
country: United States
facility: Renal Disease Research Institute
state: Texas
city: Houston
country: United States
facility: DaVita Med Center
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Fairfax
country: United States
facility: Nephrology Associates of Northern Virginia, Inc.
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Wauwatosa
country: United States
facility: Milwaukee Nephrologists, SC
state: Wisconsin
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Reservoir
country: Australia
facility: Melbourne Renal Research Group
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
city: Grenoble
country: France
facility: Chu Grenoble Alpes
city: Paris
country: France
facility: Hopital Necker, Universite Paris Descartes
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
state: Aichi
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe City
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya
state: Kanagawa
city: Kawasaki
country: Japan
facility: St Marianna University Hospital
state: Kanagawa
city: Sendai-shi
country: Japan
facility: JCHO Sendai Hospital
state: Miyagi
city: Osaka-shi
country: Japan
facility: Kitano Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga
city: Saitama-shi
country: Japan
facility: Saitama Children's Medical Center
state: Saitama
city: Bunkyō-Ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: Jutendo University Hospital
state: Tokyo
city: Fuchū
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
state: Tokyo
city: Minato-Ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Osaka
country: Japan
facility: Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
city: Rio Piedras
country: Puerto Rico
facility: Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
city: Barcelona
country: Spain
facility: Fundacio Puigvert
state: Cataluna
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
state: Murcia
Study officials:
References: