Trial · NCT03918447

A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

NCT03918447, Phase 3, Terminated, Biogen; results first posted 2024-06-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON. Trials, record NCT03918447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03918447

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
NCT number: NCT03918447
Status: Terminated
Phases: Phase 3
Enrollment: 667 participants, actual
Lead sponsor: Biogen
Conditions: Autosomal Dominant Polycystic Kidney, ADPKD
Interventions: Bardoxolone methyl oral capsule, Placebo oral capsule
First posted: 2019-04-17
Last updated: 2025-06-03
Results first posted: 2024-06-11
Limitations and caveats: Due to discontinuation of all bardoxolone chronic kidney disease programs, study was terminated early.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Off-treatment Period: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 108	Baseline, Week 108	Estimated Glomerular filtration rate (eGFR) is a measure of kidney function assessed through blood/serum. eGFR was measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m\^2). Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function. Negative change from baseline in eGFR indicates worsened kidney function.
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	From first dose of the study drug up to end of follow-up (up to Week 112)	AE:any untoward medical occurrence in a participant regardless of its causal relationship to study drug.AE can be any unfavorable \& unintended sign,symptom/disease temporally associated with use of study drug,whether considered to be study-drug related/not.This includes clinically significant abnormal laboratory test result,any newly occurring events/previous conditions that have increased in severity/frequency since administration of study drug. SAE:any AE that at any dose results in death,life-threatening,requires hospitalization/prolongation of existing hospitalisation,substantial disruption of ability to conduct normal life functions,congenital anomaly or is an important medical event. AEs \& SAEs that occurred during treatment and within 30 days after last dose were considered TE.
Secondary	Treatment Period: Change From Baseline in eGFR at Week 100	Baseline, Week 100	eGFR is a measure of kidney function assessed through blood/serum. eGFR was measured in mL/min/1.73 m\^2. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function. A negative change from baseline in eGFR indicates worsened kidney function.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Off-treatment Period: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 108	Baseline, Week 108	ITT population included all enrolled participants categorized by their randomized treatment group (whether or not they received study drug). 'Overall number of participants analyzed' indicates the number of participants with data available for this outcome measure.	mL/min/1.73 m^2	LEAST_SQUARES_MEAN
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	From first dose of the study drug up to end of follow-up (up to Week 112)	Safety population included all enrolled participants who had received at least 1 dose of study drug. Participants who received 1 dose of bardoxolone methyl were classified in the bardoxolone methyl group. Participants who received at least 1 dose of placebo and no dose of bardoxolone methyl were classified in the placebo group.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Treatment Period: Change From Baseline in eGFR at Week 100	Baseline, Week 100	ITT included all enrolled participants categorized by their randomized treatment group (whether or not they received study drug). 'Overall number of participants analyzed' indicates the number of participants with an eGFR assessment at Week 100.	mL/min/1.73 m^2	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Off-treatment Period: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 108	Bardoxolone Methyl		-4.59	Standard Error 0.817	mL/min/1.73 m^2
Off-treatment Period: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 108	Placebo		-5.56	Standard Error 0.769	mL/min/1.73 m^2
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Bardoxolone Methyl	TEAEs	314		Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo	TEAEs	296		Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Bardoxolone Methyl	Serious TEAEs	38		Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo	Serious TEAEs	26		Participants
Treatment Period: Change From Baseline in eGFR at Week 100	Bardoxolone Methyl		1.31	Standard Error 0.550	mL/min/1.73 m^2
Treatment Period: Change From Baseline in eGFR at Week 100	Placebo		-6.64	Standard Error 0.549	mL/min/1.73 m^2

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bardoxolone Methyl	334
Overall Study	STARTED	Placebo	333
Overall Study	Safety Analysis Set	Bardoxolone Methyl	335
Overall Study	Safety Analysis Set	Placebo	331
Overall Study	COMPLETED	Bardoxolone Methyl	106
Overall Study	COMPLETED	Placebo	112
Overall Study	NOT COMPLETED	Bardoxolone Methyl	228
Overall Study	NOT COMPLETED	Placebo	221

Source ClinicalTrials.gov

Adverse events216

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Bardoxolone Methyl	49	335
other	Nausea	Gastrointestinal disorders	Placebo	40	331
other	Constipation	Gastrointestinal disorders	Bardoxolone Methyl	38	335
other	Constipation	Gastrointestinal disorders	Placebo	16	331
other	Diarrhoea	Gastrointestinal disorders	Bardoxolone Methyl	35	335
other	Diarrhoea	Gastrointestinal disorders	Placebo	31	331
other	Abdominal pain	Gastrointestinal disorders	Bardoxolone Methyl	32	335
other	Abdominal pain	Gastrointestinal disorders	Placebo	21	331
other	Vomiting	Gastrointestinal disorders	Bardoxolone Methyl	23	335
other	Vomiting	Gastrointestinal disorders	Placebo	9	331

1 to 10 of 216Source ClinicalTrials.gov

See all 216 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bardoxolone Methyl	1	335
Total, all-cause mortality	Placebo	0	331
Total, other adverse events	Bardoxolone Methyl	299	335
Total, other adverse events	Placebo	255	331
Total, serious adverse events	Bardoxolone Methyl	38	335
Total, serious adverse events	Placebo	26	331

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39356039	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Bardoxolone Methyl vs Placebo: deaths from any cause	Trial comparisons
Bardoxolone Methyl vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03918447

GET https://conductscience.org/api/trials/v1/NCT03918447/events?page=2

API reference For AI assistants