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Trial record 2 of 2 for:    Alport syndrome reata

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 25, 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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Hide Hide 27 study 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: Laura Kooienga, 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, Illinois
Nephrology Research NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Principal Investigator: Stuart Sprague, 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, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Debbie Gibson, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: George Jarad, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Gerald Appel, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Kevin Meyers, 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         
Japan
St Marianna University Hospital Recruiting
Kawasaki, Japan
Principal Investigator: Yugo Shibagaki, MD         
Kobe University Hospital Recruiting
Kobe, Japan
Principal Investigator: Kandai Nozu, MD         
Saitama Children's Medical Center Recruiting
Nagoya, Japan, 457-8510
Principal Investigator: Syuichiro Fujinaga, MD         
Japanese Red Cross Nagoya Daini Hospital Recruiting
Nagoya, Japan
Principal Investigator: Yoshimitsu Gotoh, MD         
Saga University Hospital Recruiting
Saga, Japan, 849-8501
Principal Investigator: Yasufumi Ohtsuka, MD         
JCHO Sendai Hospital Recruiting
Sendai, Japan, 981-8501
Principal Investigator: Toshinobu Sato, MD         
Jutendo University Hospital Recruiting
Tokyo, Japan
Principal Investigator: Yusuke Suzuki, MD         
Tokyo Metropolitain Children's Medical Center Recruiting
Tokyo, Japan
Principal Investigator: Riku Hamada, MD         
Puerto Rico
Puerto Rico Clinical and Translational Research Consortium (PRCTRC) Recruiting
Rio Piedras, Puerto Rico, 00935
Principal Investigator: Rafael Burgos-Calderon, MD         
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: August 25, 2020
Last Verified: August 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