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

Primary Purpose

Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bardoxolone methyl
Sponsored by
Reata Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Bardoxolone methyl, CDDO-ME, RTA 402, Alport Syndrome, Autosomal Dominant Polycystic Kidney, ADPKD

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Apogee Clinical Research
  • Arizona Kidney Disease and Hypertension Research Services, PLLC
  • Centricity Research Phoenix Multispecialty
  • California Institute Renal Research
  • Academic Medical Research Institute
  • David Geffen School of Medicine at UCLA
  • Apex Research of Riverside
  • Rady Children's Hospital - San Diego
  • University of California San Francisco - Children's Renal Center
  • University of California, San Francisco
  • Western Nephrology
  • University of Colorado Anschutz Medical Center
  • Colorado Kidney Care, PC
  • South Florida Research Institute
  • Innovation Medical Research, Inc.
  • USF Health South Tampa Center
  • Florida Premier Research Institute, LLC
  • Emory University School of Medicine
  • Boise Kidney & Hypertension, PLLC
  • Boise Kidney & Hypertension, PLLC
  • Northwestern University
  • Nephrology Research NorthShore University Health System
  • University of Kansas Medical Center
  • Renal Associates of Baton Rouge
  • Northwest Louisiana Nephrology
  • The Johns Hopkins University
  • Tufts Medical Center - Division of Nephrology
  • Tufts Medical Center
  • University of Michigan
  • Nephrology Center, PC
  • Mayo Clinic
  • Children's Mercy Hospital and Clinics
  • Clinical Research Consultants, LLC
  • Washington University School of Medicine
  • KSOSN
  • Hackensack University Medical Center
  • Columbia University Medical Center
  • Mountain Kidney & Hypertension Associates
  • North Carolina Nephrology
  • Metrolina Nephrology Associates
  • Duke University Medical Center
  • Metrolina Nephrology Associates
  • Cleveland Clinic
  • Remington-Davis Clinical Research
  • Oregon Health and Science University
  • Northeast Clinical Research Center
  • Children's Hospital of Philadelphia
  • UPMC Children's Hospital of Pittsburgh
  • Columbia Nephrology Associates, PA
  • South Carolina Nephrology & Hypertension Center, Inc
  • Arlington Nephrology
  • Research Management, Inc.
  • Renal Disease Research Institute
  • DaVita Med Center
  • Southwest Houston Research
  • Clinical Advancement Center
  • University of Vermont Medical Center
  • Nephrology Associates of Northern Virginia, Inc.
  • Medical College of Wisconsin
  • Milwaukee Nephrologists, SC
  • John Hunter Hospital
  • Royal Brisbane and Women's Hospital
  • Melbourne Renal Research Group
  • The Royal Melbourne Hospital
  • Chu Grenoble Alpes
  • Hopital Necker, Universite Paris Descartes
  • Japanese Red Cross Nagoya Daini Hospital
  • Hokkaido University Hospital
  • Kobe University Hospital
  • Toranomon Hospital Kajigaya
  • St Marianna University Hospital
  • JCHO Sendai Hospital
  • Kitano Hospital
  • Osaka University Hospital
  • Saga University Hospital
  • Saitama Children's Medical Center
  • Juntendo University Hospital
  • Jutendo University Hospital
  • Tokyo Metropolitan Children's Medical Center
  • Toranomon Hospital
  • Tokyo Women's Medical University Hospital
  • Niigata University Medical and Dental Hospital
  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
  • Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
  • Fundacio Puigvert
  • Hospital Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bardoxolone methyl

Arm 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.

Outcomes

Primary Outcome Measures

Long-term safety: by incidence of adverse events and serious adverse events
Long-term safety as measured by incidence of adverse events and serious adverse events during the study duration

Secondary Outcome Measures

Full Information

First Posted
November 19, 2018
Last Updated
June 1, 2023
Sponsor
Reata Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03749447
Brief Title
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
Acronym
EAGLE
Official Title
An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Discontinuation of all bardoxolone chronic kidney disease programs
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reata Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney
Keywords
Bardoxolone methyl, CDDO-ME, RTA 402, Alport Syndrome, Autosomal Dominant Polycystic Kidney, ADPKD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bardoxolone methyl
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bardoxolone methyl
Other Intervention Name(s)
RTA 402
Intervention Description
Bardoxolone methyl capsules
Primary Outcome Measure Information:
Title
Long-term safety: by incidence of adverse events and serious adverse events
Description
Long-term safety as measured by incidence of adverse events and serious adverse events during the study duration
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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: 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); BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable; 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Apogee Clinical Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Arizona Kidney Disease and Hypertension Research Services, PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Centricity Research Phoenix Multispecialty
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
California Institute Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California San Francisco - Children's Renal Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Western Nephrology
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
University of Colorado Anschutz Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Kidney Care, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
South Florida Research Institute
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Innovation Medical Research, Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
USF Health South Tampa Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Florida Premier Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Boise Kidney & Hypertension, PLLC
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Boise Kidney & Hypertension, PLLC
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Nephrology Research NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66224
Country
United States
Facility Name
Renal Associates of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Northwest Louisiana Nephrology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts Medical Center - Division of Nephrology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02110
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Nephrology Center, PC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Children's Mercy Hospital and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
KSOSN
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mountain Kidney & Hypertension Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
North Carolina Nephrology
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Metrolina Nephrology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
Metrolina Nephrology Associates
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Remington-Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Northeast Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Columbia Nephrology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
South Carolina Nephrology & Hypertension Center, Inc
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Arlington Nephrology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Research Management, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Renal Disease Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
DaVita Med Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Southwest Houston Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Clinical Advancement Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Nephrology Associates of Northern Virginia, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Milwaukee Nephrologists, SC
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Melbourne Renal Research Group
City
Reservoir
State/Province
Victoria
ZIP/Postal Code
3073
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Chu Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Necker, Universite Paris Descartes
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe City
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Toranomon Hospital Kajigaya
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
213-8587
Country
Japan
Facility Name
St Marianna University Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
JCHO Sendai Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
981-3281
Country
Japan
Facility Name
Kitano Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8971
Country
Japan
Facility Name
Saga University Hospital
City
Saga-shi
State/Province
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Saitama Children's Medical Center
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330-8777
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Jutendo University Hospital
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Tokyo Metropolitan Children's Medical Center
City
Fuchū
State/Province
Tokyo
ZIP/Postal Code
183-8561
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-Ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
City
Osaka
ZIP/Postal Code
834-0021
Country
Japan
Facility Name
Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Fundacio Puigvert
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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