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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 : August 26, 2019
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 Drug: Bardoxolone methyl Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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 : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Bardoxolone methyl

Initial dosage is determined by proteinuria status from the last on-treatment visit in the prior qualifying study and age of the patient. 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 to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 from the prior qualifying study. Patients not meeting the following criteria may be eligible and must be discussed with the medical monitor prior to enrollment to assess their current clinical status:

    1. eGFR ≥ 30 mL/min/1.73 m2 at the last on-treatment visit in the prior qualifying study;
    2. BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study;
    3. No occurrence of a cardiovascular serious adverse event in the prior qualifying study.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study 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 taking study drug;
  • 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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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Dana Rizk, MD         
United States, Arizona
Arizona Kidney Disease and Hypertension Research Services, PLLC Recruiting
Phoenix, Arizona, United States, 85308
Principal Investigator: Peter Santos, MD         
United States, California
Academic Medical Research Institute Recruiting
Los Angeles, California, United States, 90022
Principal Investigator: Mohamed El-Shahawy, MD         
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Anjay Rastogi, MD         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Principal Investigator: Caitlin Carter, MD         
United States, Colorado
Denver Nephrologists PC Recruiting
Denver, Colorado, United States, 80230
Principal Investigator: Brad Marder, MD         
United States, Florida
South Florida Research Institute Recruiting
Lauderdale Lakes, Florida, United States, 33313
Principal Investigator: Edouard R Martin, MD         
United States, Idaho
Boise Kidney & Hypertension, PLLC Recruiting
Caldwell, Idaho, United States, 83605
Principal Investigator: Arnold L Silva, MD         
Boise Kidney & Hypertension, PLLC Recruiting
Meridian, Idaho, United States, 83642
Contact: Research Coordinator    208-846-8335      
Principal Investigator: Arnold Silva, MD         
United States, Massachusetts
Tufts Medical Center - Division of Nephrology Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02110
Principal Investigator: Lesley Inker, MD         
United States, Texas
Renal Disease Research Institute Recruiting
Dallas, Texas, United States, 75235
Principal Investigator: Bernard Fischbach, MD         
Southwest Houston Research Recruiting
Houston, Texas, United States, 77099
Principal Investigator: Marializa Bernardo, MD         
Clinical Advancement Center Recruiting
San Antonio, Texas, United States, 78215
Principal Investigator: Pablo Pergola, MD         
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.

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Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03749447     History of Changes
Other Study ID Numbers: 402-C-1803
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
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
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Nephritis, Hereditary
Urologic Diseases
Renal Insufficiency
Urogenital Abnormalities
Nephritis
Congenital Abnormalities
Collagen Diseases
Connective Tissue Diseases