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

Pivotal Trial

No Placebo-Only Group

Summary

This trial will test the safety of bardoxolone methyl in patients with chronic kidney disease who were part of earlier studies. The drug aims to improve kidney health by reducing harmful inflammation and stress. Patients will stay in the study until they choose to leave. Bardoxolone methyl has shown effectiveness in improving kidney function in patients with chronic kidney disease.

Eligible Conditions

Chronic Kidney Disease
Kidney disease
Polycystic Kidney Disease

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

60%

Headache

60%

Nausea

40%

Upper respiratory tract infection

40%

Hypokalaemia

40%

Diarrhoea

40%

Myalgia

40%

Pain in jaw

40%

Vomiting

40%

Arthralgia

40%

Oedema peripheral

40%

Bronchitis

20%

Procedural pain

20%

Sinusitis

20%

Dyspnoea

20%

Hypoxia

20%

Pulmonary congestion

20%

Musculoskeletal discomfort

20%

Hepatic enzyme increased

20%

Joint swelling

20%

Anaemia

20%

Erythema

20%

Skin ulcer

20%

Osteoarthritis

20%

Alopecia

20%

Insomnia

20%

Benign prostatic hyperplasia

20%

Asthma

20%

Influenza

20%

Gastroenteritis

20%

Constipation

20%

Dyslipidaemia

20%

Embolic stroke

20%

Hip fracture

20%

Cardiac output increased

20%

Frequent bowel movements

20%

N-terminal prohormone brain natriuretic peptide increased

20%

Venous pressure jugular increased

20%

Decreased appetite

20%

Fibromyalgia

20%

Foot deformity

20%

Dizziness

20%

Vaginal disorder

20%

Epistaxis

20%

Sinus congestion

20%

Palpitations

100%

80%

60%

40%

20%

Study treatment Arm

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 Bardoxolone Methyl 20 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 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 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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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