An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) (EAGLE)

• ClinicalTrials.gov Identifier: NCT03749447
• Recruitment Status: Recruiting
• First Posted: November 21, 2018
• Last Update Posted: December 15, 2021
• Sponsor: Reata Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Reata Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: November 19, 2018
• First Posted Date: November 21, 2018
• Last Update Posted Date: December 15, 2021
• Actual Study Start Date: March 8, 2019
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 20, 2018)

Long-term safety: by incidence of adverse events and serious adverse events [ Time Frame: Up to 5 years ]

Long-term safety as measured by incidence of adverse events and serious adverse events during the study duration

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
• Official Title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
• Brief Summary: This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Chronic Kidney Diseases
• Alport Syndrome
• Autosomal Dominant Polycystic Kidney

Intervention

Drug: Bardoxolone methyl

Bardoxolone methyl capsules

Other Name: RTA 402

Study Arms

Experimental: Bardoxolone methyl

The maximum dosage is determined by proteinuria status from the last on-treatment visit in the prior qualifying study or a screening visit, if necessary. Initial daily dose of bardoxolone methyl will dose-escalate at Week 2, Week 4, and Week 6.

Patients under the age of 18 will start dosing with bardoxolone methyl capsules every other day during Week 1 and daily at Week 2.

Patients will receive doses of bardoxolone methyl capsules in an escalating scheme from 5 mg up to no more than 30 mg.

Intervention: Drug: Bardoxolone methyl

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 21, 2020): 480
• Original Estimated Enrollment (submitted: November 20, 2018): 180
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial.

• Meets the following eligibility criteria based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable:

  1. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with eGFR <20 ml/min/1.73m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline > 1.0 ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not be eligible);
  2. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable;
  3. No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.

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 screening, taking study drug and 30 days after the last study drug dose;
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jeremy Davis; 469-442-4909; jeremy.davis@reatapharma.com

• Listed Location Countries: Australia, Japan, Puerto Rico, United States

Administrative Information

• NCT Number: NCT03749447
• Other Study ID Numbers: 402-C-1803
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Reata Pharmaceuticals, Inc.
• Study Sponsor: Reata Pharmaceuticals, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Reata Pharmaceuticals, Inc.
• Verification Date: December 2021