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Bardoxolone methyl oral capsule for Polycystic Kidney Disease (FALCON 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 first dose of the study drug up to end of follow-up (up to week 112)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a drug called bardoxolone methyl to see if it can help people with a genetic kidney disease called ADPKD. Bardoxolone methyl has shown potential in protecting against kidney damage in various studies. The drug aims to protect kidney cells by reducing harmful processes. The study will involve around 850 patients and will last for several years.

Eligible Conditions

Polycystic Kidney Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of the study drug up to end of follow-up (up to week 112)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of the study drug up to end of follow-up (up to week 112)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of the study drug up to end of follow-up (up to week 112) 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 (TEAEs) and Serious TEAEs

Off-treatment Period: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 108

Secondary study objectives

Treatment Period: Change From Baseline in eGFR at Week 100

Side effects data

From 2021 Phase 2 trial • 81 Patients • NCT04702997

23%

Muscle spasms

15%

Weight decreased

15%

Nausea

13%

Diarrhoea

13%

Vomiting

10%

Type 2 diabetes mellitus

10%

Abdominal pain

Gout

Hyperkalaemia

Alanine aminotransferase increased

Constipation

Gamma-glutamyltransferase increased

Decreased appetite

Fatigue

Oedema peripheral

Sinusitis

Urinary tract infection

Headache

Dysgeusia

Bronchitis

Aspartate aminotransferase increased

Blood alkaline phosphatase increased

Gastrooesophageal reflux disease

Haematuria

Pulmonary valve incompetence

Asthenia

Blood potassium decreased

Hepatic enzyme increased

Liver function test increased

N-terminal prohormone brain natriuretic peptide increased

Non-proliferative retinopathy

Biliary dyskinesia

Oral candidiasis

Diabetic retinopathy

Blood magnesium decreased

Arthritis

Insomnia

Hypomagnesaemia

Atelectasis

Increased appetite

Magnesium deficiency

Metabolic acidosis

Acute kidney injury

Dysuria

Cough

Rash macular

Nasopharyngitis

Vertigo

Ligament sprain

Tricuspid valve incompetence

Cataract

Diabetic retinal oedema

Cellulitis

Otitis media

Tachycardia

Corona virus infection

Ear pain

Glaucoma

Macular detachment

Skin infection

Tooth abscess

Monoclonal gammopathy

Dizziness

Paraesthesia

Confusional state

Oropharyngeal pain

Acne

Tendon rupture

Anaemia

Cardiac septal hypertrophy

Diastolic dysfunction

Left ventricular hypertrophy

Mitral valve incompetence

Abdominal pain upper

Flatulence

Stomatitis

Pyrexia

Hepatic steatosis

Brain natriuretic peptide increased

Dehydration

Fluid overload

Bursitis

Flank pain

Muscular weakness

Myalgia

Pain in extremity

Micturition urgency

Pollakiuria

Dermal cyst

Hyperhidrosis

Ingrowing nail

Skin ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Bardoxolone Methyl

Placebo

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Maximum bardoxolone methyl dose of 20 mgExperimental Treatment1 Intervention

Patients randomized to receive bardoxolone methyl with a baseline ACR less than or equal to 300 mg/g will be titrated to a maximum dose of 20 mg. Patients will begin once-daily dosing with bardoxolone methyl capsules at 5 mg and will dose escalate to 10 mg at Week 2 and 20 mg at Week 4. Patients will continue to receive study drug through Week 100, and will not receive study drug during a 12-week off-treatment period between Weeks 100 and 112.

Group II: Maximum bardoxolone methyl dose 30 mgExperimental Treatment1 Intervention

Patients randomized to receive bardoxolone methyl with a baseline ACR greater than 300 mg/g will be titrated to a maximum dose of 30 mg. Patients will begin once-daily dosing with bardoxolone methyl capsules at 5 mg and will dose escalate to 10 mg at Week 2, 20 mg at Week 4 and 30 mg at Week 6. Patients will continue to receive study drug through Week 100, and will not receive study drug during a 12-week off-treatment period between Weeks 100 and 112.

Group III: PlaceboPlacebo Group1 Intervention

Patients randomized to placebo will remain on placebo capsules throughout the study, undergoing sham titration. Patients will continue to receive placebo capsules through Week 100, and will not receive capsules during a 12-week off-treatment period between Weeks 100 and 112.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bardoxolone methyl oral capsule

2021

Completed Phase 2

~90

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