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

February 1, 2024 updated by: Reata, a wholly owned subsidiary of Biogen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Centro Médico de Córdoba
      • Corrientes, Argentina, W3400AMZ
        • Instituto de Cardiologia de Corrientes Juana Francisca Cabral
      • Rosario, Argentina, S2000DSR
        • Instituto Cardiovascular de Rosario
      • Santa Fe, Argentina, S3000EPV
        • Hospital Provincial Dr Jose Maria Cullen
    • Ciudad Autónoma De BuenosAires
      • Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1426ABP
        • Centro Medico Dra de Salvo
    • Mar Del Plata
      • Buenos Aires, Mar Del Plata, Argentina, B7600FZN
        • Instituto de Investigaciones Clínicas Mar del Plata
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
  • Belgium
      • Brussels, Belgium, 1070
        • Hospital Erasme
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven
  • Brazil
      • São Paulo, Brazil, 05403-900
        • Instituto do Coração - HCFMUSP
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
        • Irmandade Da Santa Casa de Misericordia de Porto Alegre
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-000
        • Hospital Dia do Pulmao
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Peter Lougheed Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
    • Quebec
      • Sainte Foy, Quebec, Canada, G1V 4G5
        • Centre Hospitalier de l'Universite Laval
  • Czechia
      • Prague, Czechia, 128 00
        • Vseobecna Fakultni Nemocnice v Praze
      • Prague, Czechia, 140 00
        • Institut klinicke a experimentalni mediciny
  • Germany
      • Dresden, Germany, 01307
        • Universitatsklinkum Carl Gustav Carus an der Tu
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Heidelberg, Germany, 69126
        • Thorax Klinik
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital Ein Kerem
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Sapporo, Japan, 0608648
        • Hokkaido University Hospital
      • Sendai-shi, Japan, 980-8574
        • Kurume University Medical Center
      • Suita, Japan, 5658565
        • National Cerebral and Cardiovascular Center
    • Bunkyo-ku
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Nippon Medical School Hospital
    • Hyogo
      • Kobe, Hyogo, Japan, 6500017
        • Kobe University Hospital
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
    • Mitaka-shi
      • Tokyo, Mitaka-shi, Japan, 181-8611
        • Kyorin University Hospital
    • Okayama
      • Okayama-shi, Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
  • Mexico
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 14080
        • Instituto Nacional de Cardiologia Dr. Ignacio Chavez
      • Mexico City, Distrito Federal, Mexico, 14000
        • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
    • Monterrey
      • Nuevo León, Monterrey, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64718
        • Unidad de Investigación Clínica En Medicina SC
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1007 MB
        • Vrije Universiteit Amsterdam
  • Philippines
      • Makati, Philippines, 1229
        • Makati Medical Center
      • Manila, Philippines
        • Philippine General Hospital (PGH)
    • Metro Manila
      • Quezon City, Metro Manila, Philippines, 1100
        • Philippine Heart Center
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud
    • Cantabria
      • Santander, Cantabria, Spain
        • Hospital Universitario Marques de Valdecilla
  • United Kingdom
      • Glasgow, United Kingdom, G81 4HX
        • Golden Jubilee National Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Arizona Pulmonary Specialists
      • Phoenix, Arizona, United States, 85004
        • Banner University Medical Center, Phoenix Advanced Lung Disease Institute
    • California
      • Beverly Hills, California, United States, 90211
        • Cedars Sinai Medical Center
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Los Angeles, California, United States, 90073
        • VA Healthcare System of Greater Los Angeles
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine UCLA
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center - Division of Pulmonary and Critical Care
      • Torrance, California, United States, 90502
        • Harbor - UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver - Division of Pulmonary Sciences
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center - Department of Rheumatology
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • Weston, Florida, United States, 33331
        • Cleveland Clinic of Florida
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Austell, Georgia, United States, 30106
        • Piedmont-Georgia Lung
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Associates
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center - Division of Pulmonary and Critical Care Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester - University of Rochester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Clinical Trial Center
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
      • Houston, Texas, United States, 77030
        • The University of Texas - Health Science Center & Medical School at Houston
      • Houston, Texas, United States, 77030
        • University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bardoxolone methyl 10 mg
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.
Drug: Bardoxolone methyl
Capsules of Bardoxolone methyl
Other Names:
  • RTA 402

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study
Time Frame: 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.
From time of first dose until the final visit, up to 172 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reata, a wholly owned subsidiary of Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2017

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTA 402-C-1602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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