Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
- Registration Number
- NCT03068130
- 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 pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
- Detailed Description
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.
Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.
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
- 261
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bardoxolone methyl 10 mg Bardoxolone methyl Bardoxolone 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.
- Primary Outcome Measures
Name Time Method Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study From time of first dose until the final visit, up to 172 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (96)
University of Chicago
🇺🇸Chicago, Illinois, United States
Maine Medical Center - Division of Pulmonary and Critical Care Medicine
🇺🇸Portland, Maine, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
John Hunter Hospital
🇦🇺New Lambton, New South Wales, Australia
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Hospital Dia do Pulmão
🇧🇷Blumenau, Santa Catarina, Brazil
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Instituto do Coração - HCFMUSP
🇧🇷São Paulo, Brazil
Royal Free Hospital
🇬🇧London, United Kingdom
Cedars Sinai Medical Center
🇺🇸Beverly Hills, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
UZ Leuven
🇧🇪Leuven, Vlaams Brabant, Belgium
Kitasato University Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Kurume University Medical Center
🇯🇵Sendai-shi, Japan
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
🇲🇽Ciudad de Mexico, Distrito Federal, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico City, Distrito Federal, Mexico
Philippine Heart Center
🇵🇭Quezon City, Metro Manila, Philippines
National Cerebral and Cardiovascular Center
🇯🇵Suita, Japan
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine
🇺🇸Cincinnati, Ohio, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
The University of Texas - Health Science Center & Medical School at Houston
🇺🇸Houston, Texas, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Banner University Medical Center, Phoenix Advanced Lung Disease Institute
🇺🇸Phoenix, Arizona, United States
Arizona Pulmonary Specialists
🇺🇸Phoenix, Arizona, United States
University of Colorado Denver - Division of Pulmonary Sciences
🇺🇸Aurora, Colorado, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of California Davis Medical Center - Division of Pulmonary and Critical Care
🇺🇸Sacramento, California, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
David Geffen School of Medicine UCLA
🇺🇸Los Angeles, California, United States
VA Healthcare System of Greater Los Angeles
🇺🇸Los Angeles, California, United States
Harbor - UCLA Medical Center
🇺🇸Torrance, California, United States
Piedmont-Georgia Lung
🇺🇸Austell, Georgia, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Georgetown University Medical Center - Department of Rheumatology
🇺🇸Washington, District of Columbia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Cleveland Clinic of Florida
🇺🇸Weston, Florida, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
University of Rochester - University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
🇺🇸Houston, Texas, United States
Instituto de Investigaciones Clínicas Mar Del Plata
🇦🇷Buenos Aires, Mar Del Plata, Argentina
Hospital Privado Centro Médico de Córdoba
🇦🇷Cordoba, Argentina
Centro Médico Dra de Salvo
🇦🇷Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
University of Utah
🇺🇸Salt Lake City, Utah, United States
Aurora Health Care
🇺🇸Milwaukee, Wisconsin, United States
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
🇦🇷Corrientes, Argentina
Instituto Cardiovascular de Rosario
🇦🇷Rosario, Argentina
Hospital Provincial Dr Jose Maria Cullen
🇦🇷Santa Fe, Argentina
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Hospital Erasme
🇧🇪Brussels, Belgium
Irmandade Da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Peter Lougheed Centre
🇨🇦Calgary, Alberta, Canada
Centre Hospitalier de l'Université Laval
🇨🇦Sainte Foy, Quebec, Canada
Thorax Klinik
🇩🇪Heidelberg, Germany
Vseobecna fakultni nemocnice v Praze
🇨🇿Prague, Czechia
Institut klinicke a experimentalni mediciny
🇨🇿Prague, Czechia
Universitatsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Hadassah University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
Universitatsklinkum Carl Gustav Carus an der Tu
🇩🇪Dresden, Germany
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Nippon Medical School Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Kyorin University Hospital
🇯🇵Tokyo, Mitaka-shi, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama-shi, Okayama, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Japan
Unidad de Investigación Clínica En Medicina SC
🇲🇽Monterrey, Nuevo Leon, Mexico
Vrije Universiteit Amsterdam
🇳🇱Amsterdam, Noord-Holland, Netherlands
Hospital Universitario Dr. Jose Eleuterio Gonzalez
🇲🇽Nuevo León, Monterrey, Mexico
Makati Medical Center
🇵🇭Makati, Philippines
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Philippine General Hospital (PGH)
🇵🇭Manila, Philippines
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Virgen de La Salud
🇪🇸Toledo, Spain
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States