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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749447
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Alport Syndrome Autosomal Dominant Polycystic Kidney Drug: Bardoxolone methyl Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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.

Drug: Bardoxolone methyl
Bardoxolone methyl capsules
Other Name: RTA 402




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749447


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

Locations
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Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
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Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03749447    
Other Study ID Numbers: 402-C-1803
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reata Pharmaceuticals, Inc.:
Bardoxolone methyl
CDDO-ME
RTA 402
Alport Syndrome
Autosomal Dominant Polycystic Kidney
ADPKD
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Nephritis, Hereditary
Urologic Diseases
Renal Insufficiency
Congenital Abnormalities
Kidney Diseases, Cystic
Abnormalities, Multiple
Ciliopathies
Genetic Diseases, Inborn
Urogenital Abnormalities
Nephritis
Collagen Diseases
Connective Tissue Diseases