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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 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
8%
Gout
8%
Hyperkalaemia
8%
Alanine aminotransferase increased
8%
Constipation
8%
Gamma-glutamyltransferase increased
8%
Decreased appetite
5%
Fatigue
5%
Oedema peripheral
5%
Sinusitis
5%
Urinary tract infection
5%
Headache
5%
Dysgeusia
5%
Bronchitis
5%
Aspartate aminotransferase increased
5%
Blood alkaline phosphatase increased
5%
Gastrooesophageal reflux disease
5%
Haematuria
3%
Pulmonary valve incompetence
3%
Asthenia
3%
Blood potassium decreased
3%
Hepatic enzyme increased
3%
Liver function test increased
3%
N-terminal prohormone brain natriuretic peptide increased
3%
Non-proliferative retinopathy
3%
Biliary dyskinesia
3%
Oral candidiasis
3%
Diabetic retinopathy
3%
Blood magnesium decreased
3%
Arthritis
3%
Insomnia
3%
Hypomagnesaemia
3%
Atelectasis
3%
Increased appetite
3%
Magnesium deficiency
3%
Metabolic acidosis
3%
Acute kidney injury
3%
Dysuria
3%
Cough
3%
Rash macular
3%
Nasopharyngitis
3%
Vertigo
3%
Ligament sprain
3%
Tricuspid valve incompetence
3%
Cataract
3%
Diabetic retinal oedema
3%
Cellulitis
3%
Otitis media
3%
Tachycardia
3%
Corona virus infection
3%
Ear pain
3%
Glaucoma
3%
Macular detachment
3%
Skin infection
3%
Tooth abscess
3%
Monoclonal gammopathy
3%
Dizziness
3%
Paraesthesia
3%
Confusional state
3%
Oropharyngeal pain
3%
Acne
3%
Tendon rupture
3%
Anaemia
3%
Cardiac septal hypertrophy
3%
Diastolic dysfunction
3%
Left ventricular hypertrophy
3%
Mitral valve incompetence
3%
Abdominal pain upper
3%
Flatulence
3%
Stomatitis
3%
Pyrexia
3%
Hepatic steatosis
3%
Brain natriuretic peptide increased
3%
Dehydration
3%
Fluid overload
3%
Bursitis
3%
Flank pain
3%
Muscular weakness
3%
Myalgia
3%
Pain in extremity
3%
Micturition urgency
3%
Pollakiuria
3%
Dermal cyst
3%
Hyperhidrosis
3%
Ingrowing nail
3%
Skin ulcer
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
645 Previous Clinical Trials
466,726 Total Patients Enrolled
Reata, a wholly owned subsidiary of BiogenLead Sponsor
49 Previous Clinical Trials
6,095 Total Patients Enrolled
Reata Pharmaceuticals, Inc.Lead Sponsor
51 Previous Clinical Trials
6,233 Total Patients Enrolled
~104 spots leftby Nov 2025
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