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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT03749447
• Date of registration: 19/11/2018
• Prospective Registration: Yes
• Primary sponsor: Reata, a wholly owned subsidiary of Biogen
• Public title: An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) EAGLE
• Scientific title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
• Date of first enrolment: March 8, 2019
• Target sample size: 270
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03749447
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, France, Japan, Puerto Rico, Spain, United States

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Diseases

Alport Syndrome

Autosomal Dominant Polycystic Kidney

Intervention(s)

Drug: Bardoxolone methyl

Primary Outcome(s)

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

Secondary ID(s)

2018-003253-24

402-C-1803

Source(s) of Monetary Support

Please refer to primary and secondary sponsors