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

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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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Long-term safety: by incidence of adverse events and serious adverse events


Condition

Chronic Kidney Diseases

Intervention

Bardoxolone methyl

Study Arms / Comparison Groups

 Bardoxolone methyl
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

480

Start Date

March 8, 2019

Completion Date

December 2025

Primary Completion Date

December 2025

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.
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 469-442-4909, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03749447

Organization ID

402-C-1803


Responsible Party

Sponsor

Study Sponsor

Reata Pharmaceuticals, Inc.


Study Sponsor

, , 


Verification Date

December 2020