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Bardoxolone methyl for Chronic Kidney Disease (EAGLE Trial)

Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)
Awards & highlights

EAGLE Trial Summary

This trial will study the long-term safety and tolerability of an experimental drug, bardoxolone methyl, in patients with chronic kidney disease who have previously taken the drug in another trial. The trial will end when the drug is commercially available or when patients withdraw from the trial.

Eligible Conditions
  • Chronic Kidney Disease
  • Alport Syndrome
  • Polycystic Kidney Disease

EAGLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Side effects data

From 2018 Phase 2 trial • 166 Patients • NCT02036970
22%
Constipation
22%
Pneumonia
22%
Hypokalaemia
22%
Fluid overload
22%
Vomiting
22%
Bronchitis
11%
Chest discomfort
11%
Transient ischaemic attack
11%
Right ventricular failure
11%
Sinusitis
11%
Upper respiratory tract infection
11%
International normalised ratio increased
11%
Hypoxia
11%
Gastritis
11%
Vaginal haemorrhage
11%
Lactic acidosis
11%
Fluid retention
11%
Alopecia
11%
Urinary retention
11%
Mediastinal mass
11%
Menopause
11%
Abdominal pain
11%
Gastrooesophageal reflux disease
11%
Flushing
11%
Hepatic cyst
11%
Muscle spasms
11%
Ageusia
11%
Gastrointestinal haemorrhage
11%
Anaemia
11%
Dyspnoea
11%
Arthralgia
11%
Iron deficiency anaemia
11%
Diarrhoea
11%
Chills
11%
Vision blurred
11%
Pericardial effusion
11%
Cataract
11%
Nausea
11%
Headache
11%
Viral upper respiratory tract infection
11%
Fatigue
11%
Gastrointestinal infection
11%
Nasopharyngitis
11%
Urosepsis
11%
Syncope
11%
Pulmonary arterial hypertension
11%
Hypotension
11%
Hiatus hernia
11%
Non-cardiac chest pain
11%
Cholelithiasis
11%
Herpes zoster
11%
Oesophageal candidiasis
11%
Otitis externa
11%
Urinary tract infection
11%
Viral infection
11%
Procedural pain
11%
Pulmonary arterial pressure increased
11%
Iron deficiency
11%
Pain in jaw
11%
Dizziness
11%
Confusional state
11%
Libido decreased
11%
Epistaxis
11%
Nasal congestion
11%
Pulmonary congestion
11%
Flatulence
11%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label
Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label
Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label
Part 1 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg
Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label
Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label
Part 2 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg
Part 2 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg
Part 2 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg
Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label
Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label
Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label
Part 2 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg
Part 1 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg
Part 1 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg
Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg
Part 1 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg
Part 1 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg
Part 2 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg
Part 2 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg

EAGLE Trial Design

1Treatment groups
Experimental Treatment
Group I: Bardoxolone methylExperimental Treatment1 Intervention
Adult participants received bardoxolone methyl capsules, once daily (QD) at a starting dose of 5 milligrams (mg), followed by dose- escalation to 10 mg at Week 2 (Day 14 ± 3), and to 20 mg at Week 4 (Day 28 ± 3). Based on the eligibility UACR >300 milligrams per gram (mg/g), the dose was increased to 30 mg starting from Week 6 (Day 42 ± 3) until the end of the study. Participants under 18 years of age received bardoxolone methyl capsules at a starting dose of 5 mg every other day during the first week and QD during the second week of the study, followed by dose-escalation to 10 mg at Week 2 and to 20 mg at Week 4. Based on the eligibility UACR >300 mg/g, the dose was increased to 30 mg starting from Week 6 until the end of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bardoxolone methyl
2014
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,166 Total Patients Enrolled
Reata, a wholly owned subsidiary of BiogenLead Sponsor
45 Previous Clinical Trials
6,140 Total Patients Enrolled
Reata Pharmaceuticals, Inc.Lead Sponsor
51 Previous Clinical Trials
6,630 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical clinics is this research study being conducted today?

"There are 52 clinical research sites participating in this trial, including locations like Research Management, Inc. in Austin, Metrolina Nephrology Associates in Gastonia, and Southwest Houston Research in Houston."

Answered by AI

Is Bardoxolone methyl a new medication?

"Bardoxolone methyl was first studied in 2018 at Japan Community Health care Organization Sendai Hospital, and there have been 19 completed trials since then. There are 3 ongoing trials at the moment, a significant portion of which are based in Austin, Texas."

Answered by AI

Has Bardoxolone methyl received FDA approval for use?

"Bardoxolone methyl has received a safety score of 3. This is based on the fact that it is in Phase 3 clinical trials, which suggests that not only is there some data supporting its efficacy, but also that there have been multiple rounds of data collected backing up its safety."

Answered by AI

How many people are enrolled in this experiment at most?

"This clinical trial needs 480 participants that fit the pre-determined inclusion criteria. The research is being conducted out of different locations including Research Management, Inc. in Austin, Texas and Metrolina Nephrology Associates in Gastonia, North carolina."

Answered by AI

Are there any patients still needed for this particular clinical trial?

"That is accurate. The clinicaltrials.gov website does indicate that this research project, which was originally published on March 8th 2019, is still recruiting subjects. In total, they need 480 individuals at 52 different locations."

Answered by AI

Is this research the first attempt at investigating this medical phenomenon?

"Bardoxolone methyl is being studied in 3 ongoing trials spread out over 11 countries and 110 cities. The first clinical trial was sponsored by Kyowa Kirin Co., Ltd. in 2018 and completed its Phase 3 drug approval stage that same year. A total of 1323 patients were involved. Since then, 19 more trials have been completed."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Massachusetts
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Arizona Kidney Disease and Hypertension Research Services, PLLC
Tufts Medical Center - Division of Nephrology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
2019. "An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03749447.
~44 spots leftby Apr 2025
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