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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 112 weeks
Awards & highlights

FALCON Trial Summary

This trial will study if bardoxolone methyl is safe and effective in treating patients with ADPKD. 850 patients will be enrolled.

Eligible Conditions
  • Polycystic Kidney Disease

FALCON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~112 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 112 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in eGFR from baseline (108 weeks)
Count of reported adverse events
Secondary outcome measures
Change in eGFR from baseline (100 weeks)

Side effects data

From 2021 Phase 2 trial • 81 Patients • NCT04702997
23%
Muscle spasms
15%
Nausea
15%
Weight decreased
13%
Diarrhoea
13%
Vomiting
10%
Type 2 diabetes mellitus
10%
Abdominal pain
8%
Hyperkalaemia
8%
Gout
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%
Blood potassium decreased
3%
Magnesium deficiency
3%
Acute kidney injury
3%
Pulmonary valve incompetence
3%
Dysuria
3%
Hypomagnesaemia
3%
Metabolic acidosis
3%
Asthenia
3%
Blood magnesium decreased
3%
Rash macular
3%
Increased appetite
3%
Arthritis
3%
Oral candidiasis
3%
Cough
3%
Atelectasis
3%
Nasopharyngitis
3%
Vertigo
3%
Ligament sprain
3%
Tricuspid valve incompetence
3%
Cataract
3%
Diabetic retinal oedema
3%
Diabetic retinopathy
3%
Non-proliferative retinopathy
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%
Biliary dyskinesia
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%
Hepatic enzyme increased
3%
Liver function test increased
3%
N-terminal prohormone brain natriuretic peptide increased
3%
Dehydration
3%
Fluid overload
3%
Bursitis
3%
Flank pain
3%
Muscular weakness
3%
Myalgia
3%
Pain in extremity
3%
Insomnia
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

FALCON 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
639 Previous Clinical Trials
466,690 Total Patients Enrolled
Reata, a wholly owned subsidiary of BiogenLead Sponsor
45 Previous Clinical Trials
5,743 Total Patients Enrolled
Reata Pharmaceuticals, Inc.Lead Sponsor
51 Previous Clinical Trials
6,233 Total Patients Enrolled

Frequently Asked Questions

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

Are adolescents eligible for participation in this research?

"Eligibility for this clinical trial requires that potential participants must between 12 and 70 years old."

Answered by AI

What are the risks associated with Bardoxolone methyl oral capsule?

"Bardoxolone methyl oral capsule is safe according to our team's evaluation. We gave it a 3 because there is already some efficacy data from previous trials and multiple rounds of safety data."

Answered by AI

Are there any other Bardoxolone methyl oral capsule clinical trials I can review?

"There are currently 3 ongoing Bardoxolone methyl oral capsule clinical trials taking place, with the majority being located in Tokyo and California. A total of 221 research facilities are conducting these clinical trials."

Answered by AI

Is this a new and innovative way to test treatments?

"Bardoxolone methyl oral capsule is being studied in 3 ongoing trials across 11 nations and 110 cities. The first study of Bardoxolone methyl oral capsule was completed in 2018 by Kyowa Kirin Co., Ltd. That trial reached Phase 3 drug approval and involved 1323 patients. Since 2018, 191 additional trials have been completed."

Answered by AI

Could you please describe the ideal candidate for this research project?

"This study is looking for 850 participants that suffer from arthrogryposis. The age requirement for potential candidates is 12-70. To be eligible, the following additional criteria must be met: being male or female, a diagnosis of ADPKD, eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2, albumin to creatinine ratio (ACR) ≤ 2500 mg/g, and systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg."

Answered by AI

Is this clinical trial taking place predominantly in North America?

"There are 78 different sites running this trial, which are situated in cities including Flushing, Bethlehem, and Houston. To limit the amount of travel required, patients are encouraged to select the site that is closest to them."

Answered by AI

Is it possible to join this experiment at this time?

"That is correct. As can be seen on clinicaltrials.gov, this trial is presently looking for participants. The study was first posted on 5/29/2019 and was most recently updated on 6/2/2022. A total of 850 patients need to be enrolled from 78 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Arlington Nephrology, PA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
2019. "A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03918447.
~114 spots leftby Apr 2025
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