RANGER

Principal Investigator: John  Ryan
Keywords: pulmonary hypertension , clinical trial , bardoxolone methyl Department: Cardiovascular Medicine
IRB Number: 00100674 Co Investigator: Nathan  Hatton
Specialty: Cardiology, Pulmonary
Sub Specialties: Pulmonary
Recruitment Status: Enrolling by invitation

Contact Information

John Kirk
john.kirk@hsc.utah.edu
801-585-2944

Brief Summary

Primary Objective:

To provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl.

 

Detailed Description

The established pharmacologic effects of bardoxolone methyl, including the suppression of pathologic NF-κB signaling and inflammation and mitochondrial dysfunction, are directly applicable to the treatment of PH. Despite available therapies, the prognosis for PH remains poor, especially for patients with CTD (Chung, 2014) and ILD. Given the severity of the underlying disease, this study seeks to offer patients who previously participated in clinical studies extended access to bardoxolone methyl until it is available through commercial channels (including reimbursement).

Inclusion Criteria

  1. 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

  1. 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;
  2. Patients who have an ongoing serious adverse event (SAE) from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
  3. 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;
  4. Women who are pregnant or breastfeeding;
  5. 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;
  6. Known hypersensitivity to any component of the study drug.