Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER

Pulmonary Hypertension Clinical Trial

— RANGER  

Official title:

An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03068130
• Other study ID #: RTA 402-C-1602
• Status: Terminated
• Phase: Phase 3
• Start date: April 18, 2017
• Est. completion date: September 30, 2020

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 pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.

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 information / eligibility

• Status: Terminated
• Enrollment: 261
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

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 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Bardoxolone methyl
Capsules of Bardoxolone methyl

Locations

Country	Name	City	State
Argentina	Centro Médico Dra de Salvo	Buenos Aires	Ciudad Autónoma De BuenosAires
Argentina	Instituto de Investigaciones Clínicas Mar Del Plata	Buenos Aires	Mar Del Plata
Argentina	Hospital Privado Centro Médico de Córdoba	Cordoba
Argentina	Instituto de Cardiologia de Corrientes Juana Francisca Cabral	Corrientes
Argentina	Instituto Cardiovascular de Rosario	Rosario
Argentina	Hospital Provincial Dr Jose Maria Cullen	Santa Fe
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	John Hunter Hospital	New Lambton	New South Wales
Belgium	Hospital Erasme	Brussels
Belgium	UZ Leuven	Leuven	Vlaams Brabant
Brazil	Hospital Dia do Pulmão	Blumenau	Santa Catarina
Brazil	Irmandade Da Santa Casa de Misericordia de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto do Coração - HCFMUSP	São Paulo
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre Hospitalier de l'Université Laval	Sainte Foy	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
Czechia	Institut klinicke a experimentalni mediciny	Prague
Czechia	Vseobecna fakultni nemocnice v Praze	Prague
Germany	Universitatsklinkum Carl Gustav Carus an der Tu	Dresden
Germany	Universitatsklinikum Hamburg Eppendorf	Hamburg
Germany	Thorax Klinik	Heidelberg
Israel	Hadassah University Hospital Ein Kerem	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Japan	Chiba University Hospital	Chiba
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	National Hospital Organization Okayama Medical Center	Okayama-shi	Okayama
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Hokkaido University Hospital	Sapporo
Japan	Kurume University Medical Center	Sendai-shi
Japan	National Cerebral and Cardiovascular Center	Suita
Japan	Kyorin University Hospital	Tokyo	Mitaka-shi
Japan	Nippon Medical School Hospital	Tokyo	Bunkyo-ku
Mexico	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	Unidad de Investigación Clínica En Medicina SC	Monterrey	Nuevo Leon
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Nuevo León	Monterrey
Netherlands	Vrije Universiteit Amsterdam	Amsterdam	Noord-Holland
Philippines	Makati Medical Center	Makati
Philippines	Philippine General Hospital (PGH)	Manila
Philippines	Philippine Heart Center	Quezon City	Metro Manila
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Virgen de La Salud	Toledo
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Royal Free Hospital	London
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Augusta University	Augusta	Georgia
United States	University of Colorado Denver - Division of Pulmonary Sciences	Aurora	Colorado
United States	Piedmont-Georgia Lung	Austell	Georgia
United States	Cedars Sinai Medical Center	Beverly Hills	California
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
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	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
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	University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics	Houston	Texas
United States	University of California San Diego	La Jolla	California
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	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Aurora Health Care	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	NYU Langone Medical Center	New York	New York
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Pulmonary Specialists	Phoenix	Arizona
United States	Banner University Medical Center, Phoenix Advanced Lung Disease Institute	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Maine Medical Center - Division of Pulmonary and Critical Care Medicine	Portland	Maine
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Rochester - University of Rochester Medical Center	Rochester	New York
United States	University of California Davis Medical Center - Division of Pulmonary and Critical Care	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Harbor - UCLA Medical Center	Torrance	California
United States	Georgetown University Medical Center - Department of Rheumatology	Washington	District of Columbia
United States	Cleveland Clinic of Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Germany,  Israel,  Japan,  Mexico,  Netherlands,  Philippines,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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