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

• ClinicalTrials.gov Identifier: NCT03749447
• Recruitment Status: Recruiting
• First Posted: November 21, 2018
• Last Update Posted: December 4, 2020
• Sponsor: Reata Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Reata Pharmaceuticals, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

University of California San Francisco - Children's Renal Center; Recruiting

San Francisco, California, United States, 94143

Principal Investigator: Ferzana Perwad, 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

Children's Mercy Hospital and Clinics; Recruiting

Kansas City, Missouri, United States, 64108

Principal Investigator: Bradley Warady, MD

Washington University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63110

Principal Investigator: George Jarad, MD

United States, New Jersey

Hackensack University Medical Center; Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator: Kenneth Lieberman

United States, New York

Nephrology Associates, PC; Recruiting

Flushing, New York, United States, 11355

Principal Investigator: Bruce Spinowitz, MD

Columbia University Medical Center; Recruiting

New York, New York, United States, 10032

Principal Investigator: Gerald Appel, MD

United States, Oregon

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

Principal Investigator: Amira Al-Uzri, MD

United States, Pennsylvania

Children's Hospital of Philadelphia; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator: Kevin Meyers, MD

UPMC Children's Hospital of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Principal Investigator: Michael Moritz, MD

United States, South Carolina

South Carolina Nephrology & Hypertension Center, Inc; Recruiting

Orangeburg, South Carolina, United States, 29118

Principal Investigator: Moustafa Moustafa, 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

Australia, New South Wales

John Hunter Hospital; Recruiting

New Lambton, New South Wales, Australia, 2305

Principal Investigator: Alastair Gillies, MD

Australia, Queensland

Royal Brisbane and Women's Hospital; Recruiting

Herston, Queensland, Australia, 2305

Principal Investigator: Martin Wolley, MD

Australia, Victoria

Melbourne Renal Research Group; Recruiting

Reservoir, Victoria, Australia, 3073

Principal Investigator: David Packham, 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

Kitano Hospital; Recruiting

Osaka, Japan

Principal Investigator: Tatsuo Tsukamoto, 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.

More Information

• Responsible Party: Reata Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03749447
• Other Study ID Numbers: 402-C-1803
• First Posted: November 21, 2018
• Last Update Posted: December 4, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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