Study Stopped
The company determined that continued exposure of these high-risk PH patients to clinic or in-person visits during the COVID pandemic presented an unacceptable risk.
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
RANGER
An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
1 other identifier
interventional
261
15 countries
96
Brief Summary
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2017
Typical duration for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedStudy Start
First participant enrolled
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedResults Posted
Study results publicly available
October 12, 2023
CompletedJune 11, 2025
May 1, 2025
3.5 years
February 22, 2017
September 18, 2023
May 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study
Severity was defined using the following definitions: Mild: Symptoms causing no or minimal interference with usual social and functional activities; Moderate: Symptoms causing greater than minimal interference with usual social and functional activities; Severe: Symptoms causing inability to perform usual social and functional activities.
From time of first dose until the final visit, up to 172 weeks
Study Arms (1)
Bardoxolone methyl 10 mg
EXPERIMENTALBardoxolone methyl will be administered orally once daily at 10 mg until it becomes commercially available. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.
Interventions
Eligibility Criteria
You may qualify if:
- Treatment-compliant patients who are participating in qualifying ongoing studies and have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl
You may not qualify if:
- 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 taking study drug;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (96)
Banner University Medical Center, Phoenix Advanced Lung Disease Institute
Phoenix, Arizona, 85004, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012, United States
Cedars Sinai Medical Center
Beverly Hills, California, 90211, United States
University of California San Diego
La Jolla, California, 92093, United States
VA Healthcare System of Greater Los Angeles
Los Angeles, California, 90073, United States
David Geffen School of Medicine UCLA
Los Angeles, California, 90095, United States
University of California Davis Medical Center - Division of Pulmonary and Critical Care
Sacramento, California, 95817, United States
Harbor - UCLA Medical Center
Torrance, California, 90502, United States
University of Colorado Denver - Division of Pulmonary Sciences
Aurora, Colorado, 80045, United States
Georgetown University Medical Center - Department of Rheumatology
Washington D.C., District of Columbia, 20007, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Cleveland Clinic of Florida
Weston, Florida, 33331, United States
Augusta University
Augusta, Georgia, 30912, United States
Piedmont-Georgia Lung
Austell, Georgia, 30106, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202, United States
Maine Medical Center - Division of Pulmonary and Critical Care Medicine
Portland, Maine, 04102, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
NYU Langone Medical Center
New York, New York, 10016, United States
University of Rochester - University of Rochester Medical Center
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas, 77030, United States
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Aurora Health Care
Milwaukee, Wisconsin, 53215, United States
Centro Médico Dra de Salvo
Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina
Instituto de Investigaciones Clínicas Mar Del Plata
Buenos Aires, Mar Del Plata, B7600FZN, Argentina
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes, W3400AMZ, Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, X5016KEH, Argentina
Instituto Cardiovascular de Rosario
Rosario, S2000DSR, Argentina
Hospital Provincial Dr Jose Maria Cullen
Santa Fe, S3000EPV, Argentina
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
Hospital Erasme
Brussels, 1070, Belgium
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
Hospital Dia do Pulmão
Blumenau, Santa Catarina, 89010-000, Brazil
Instituto do Coração - HCFMUSP
São Paulo, 05403-900, Brazil
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Centre Hospitalier de l'Université Laval
Sainte-Foy, Quebec, G1V 4G5, Canada
Vseobecna fakultni nemocnice v Praze
Prague, 128 00, Czechia
Institut klinicke a experimentalni mediciny
Prague, 140 00, Czechia
Universitatsklinkum Carl Gustav Carus an der Tu
Dresden, 01307, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Thorax Klinik
Heidelberg, 69126, Germany
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603, Japan
Kobe University Hospital
Kobe, Hyōgo, 6500017, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375, Japan
Kyorin University Hospital
Tokyo, Mitaka-shi, 181-8611, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Hokkaido University Hospital
Sapporo, 0608648, Japan
Kurume University Medical Center
Sendai, 980-8574, Japan
National Cerebral and Cardiovascular Center
Suita, 5658565, Japan
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000, Mexico
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
Mexico City, Mexico City, 14080, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Nuevo León, Monterrey, 64460, Mexico
Unidad de Investigación Clínica En Medicina SC
Monterrey, Nuevo León, 64718, Mexico
Vrije Universiteit Amsterdam
Amsterdam, North Holland, 1007 MB, Netherlands
Philippine Heart Center
Quezon City, National Capital Region, 1100, Philippines
Makati Medical Center
Makati, 1229, Philippines
Philippine General Hospital (PGH)
Manila, Philippines
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Hospital Virgen de La Salud
Toledo, 45004, Spain
Golden Jubilee National Hospital
Glasgow, G81 4HX, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- US Biogen Clinical Trial Center
- Organization
- Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2017
First Posted
March 1, 2017
Study Start
April 18, 2017
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
June 11, 2025
Results First Posted
October 12, 2023
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/