Study Stopped
Discontinuation of all bardoxolone chronic kidney disease programs
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
FALCON
A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease
1 other identifier
interventional
667
10 countries
137
Brief Summary
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2019
Typical duration for phase_3
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
May 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2023
CompletedResults Posted
Study results publicly available
June 11, 2024
CompletedJune 3, 2025
May 1, 2025
4.2 years
April 12, 2019
April 26, 2024
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Off-treatment Period: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at 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.
Baseline, Week 108
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
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.
From first dose of the study drug up to end of follow-up (up to Week 112)
Secondary Outcomes (1)
Treatment Period: Change From Baseline in eGFR at Week 100
Baseline, Week 100
Study Arms (3)
Maximum bardoxolone methyl dose of 20 mg
EXPERIMENTALPatients 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.
Maximum bardoxolone methyl dose 30 mg
EXPERIMENTALPatients 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.
Placebo
PLACEBO COMPARATORPatients 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.
Interventions
Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.
Eligibility Criteria
You may qualify if:
- Male and female patients 12 ≤ age ≤ 70 upon study consent;
- Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73 m2 (12 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years):
- \) Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor discretion); 2)The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference ≤ 25%;
- Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit;
- Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A or B visit after a period of rest.
You may not qualify if:
- History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 2 months prior to the Screen A visit;
- B-type natriuretic peptide (BNP) level \> 200 pg/mL at Screen A visit;
- Uncontrolled diabetes (HbA1c \> 11.0%) at Screen A visit;
- Serum albumin \< 3 g/dL at Screen A visit;
- History of intracranial aneurysms;
- Kidney or any other solid organ transplant recipient or a planned transplant during the study;
- Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
- History of clinically significant left-sided heart disease and/or clinically significant cardiac disease;
- Systolic BP \< 90 mm Hg at Screen A visit after a period of rest;
- BMI \< 18.5 kg/m2 at the Screen A visit;
- History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas;
- Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
- Untreated or uncontrolled active bacterial, fungal, or viral infection;
- Participation in other interventional clinical studies within 30 days prior to Day 1;
- Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (137)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Nephrology Associates PC
Homewood, Alabama, 35209, United States
Nephrology Consultants, LLC
Huntsville, Alabama, 35805, United States
AKDHC
Glendale, Arizona, 85306, United States
Aventiv Research, Inc
Mesa, Arizona, 85210, United States
University of Arizona
Tucson, Arizona, 85719, United States
Rancho Research Institute
Downey, California, 90242, United States
California Institute Renal Research
La Mesa, California, 91942, United States
University of California, Los Angeles
Los Angeles, California, 90025, United States
Keck USC/LAC
Los Angeles, California, 90033, United States
Amicis Research Center
Northridge, California, 91324, United States
Stanford University
Palo Alto, California, 94304, United States
Apex Research of Riverside
Riverside, California, 92505, United States
University of California San Francisco
San Francisco, California, 94143, United States
Western Nephrology
Arvada, Colorado, 80002, United States
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045, United States
Kidney Associates of Colorado
Denver, Colorado, 80210, United States
Denver Nephrologist, PC
Denver, Colorado, 80230, United States
Western Nephrology and Mineral Bone Disease, PC
Westminster, Colorado, 80031, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
University of Miami
Miami, Florida, 33136, United States
Pro-Care Research Center, Corp.
Miami Gardens, Florida, 33014, United States
Discovery Medical Research Group
Ocala, Florida, 34471, United States
Innovation Medical Research Center, Inc
Palmetto Bay, Florida, 33157, United States
Volunteer Medical Research
Port Charlotte, Florida, 33952, United States
University of South Florida
Tampa, Florida, 33606, United States
Florida Premier Research Institute, LLC
Winter Park, Florida, 32789, United States
Emory University
Atlanta, Georgia, 30322, United States
Georgia Nephrology, LLC
Lawrenceville, Georgia, 30046, United States
Boise Kidney & Hypertension, PLLC
Caldwell, Idaho, 83605, United States
Boise Kidney & Hypertension, PLLC
Meridian, Idaho, 83642, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60617, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
University of Kansas Medical Center
Kansas City, Kansas, 66224, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Ascension Via Christi Research
Wichita, Kansas, 67214, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, 67214, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
The Johns Hopkins University
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
KidneyCare and Tranplant Services of New England
Springfield, Massachusetts, 01104, United States
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, 01107, United States
Paragon Health PC d/b/a Nephrology Center PC
Kalamazoo, Michigan, 49007, United States
Michigan Kidney Consultants
Pontiac, Michigan, 48341, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
KSOSN
Las Vegas, Nevada, 89129, United States
Nephrology Associates, P.C.
Flushing, New York, 11355, United States
Division of Kidney Diseases and Hypertension
Great Neck, New York, 11021, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, 28204, United States
North Carolina Nephrology, P.A. 2nd Floor
Raleigh, North Carolina, 27609, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Remington-Davis Clinical Research
Columbus, Ohio, 43215, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19014, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203, United States
Nephrology Associates, P.C.
Nashville, Tennessee, 37205, United States
TTUHSC
Amarillo, Texas, 79106, United States
Arlington Nephrology, PA
Arlington, Texas, 76015, United States
Research Management, Inc.
Austin, Texas, 78751, United States
Research Management, Inc.
Austin, Texas, 78758, United States
Liberty Research Center
Dallas, Texas, 75230, United States
Renal Disease Research Institute
Dallas, Texas, 75235, United States
Davita Clinical Research
El Paso, Texas, 79925, United States
DaVita Med Center
Houston, Texas, 77004, United States
Clinical Advancement Center
San Antonio, Texas, 78215, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, 22033, United States
Swedish Medical Center
Seattle, Washington, 98052, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Milwaukee Nephrologists, SC
Wauwatosa, Wisconsin, 53226, United States
Renal Research
Gosford, New South Wales, 2250, Australia
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Melbourne Health
Parkville, Victoria, 3050, Australia
Melbourne Renal Research Group
Reservoir, Victoria, 3073, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Nephrology, Cliniques U St-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Brussel (VUB)
Brussels, B-1090, Belgium
University Hospitals Leuven, Dept. of Nephrology, Dialysis and Renal Transplantation
Leuven, 3000, Belgium
Chu Liege
Liège, 4000, Belgium
FN Brno
Brno, 62500, Czechia
Nephrology Dept., General Teaching Hospital
Prague, 12808, Czechia
IKEM
Prague, 14021, Czechia
University Hospital La Cavale Blanche
Brest, 29200, France
Chu Grenoble Alpes
Grenoble, 38043, France
Hospital Henri-Mondor AP-HP
Le Kremlin-Bicêtre, 94270, France
CHU de Nantes
Nantes, 44093, France
Hopital Necker, Universite Paris Descartes
Paris, 75015, France
Universitätsklinikum Essen
Essen, 45147, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Klinikum rechts der Isar der TU München
München, 81675, Germany
Renal Division, ASST Santi Paolo e Carlo
Milan, 20153, Italy
Università di Modena e Reggio Emilia
Modena, 41124, Italy
ICS Maugeri SpA SB
Pavia, 27100, Italy
Fondazione Policlinico Gemelli
Roma, 168, Italy
Hokkaido University Hospital
Hokkaido, 060-8648, Japan
Toranomon Hospital Kajigaya
Kanagawa, 213-8587, Japan
Japan Community Healthcare Organization Sendai Hospital
Miyagi, 981-8501, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Osaka University Hospital
Osaka, 565-0871, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Tokyo Women's Medical University Hospital
Tokyo, 162-8666, Japan
Hospital Universitario de Badajoz
Badajoz, 6070, Spain
Hospital Del Mar
Barcelona, 8003, Spain
Fundacio Puigvert
Barcelona, 8025, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18012, Spain
Hospital Lucus Augusti
Lugo, 27003, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital de Getafe
Madrid, 28905, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Universitario Dr Peset
Valencia, 46017, Spain
North Bristol NHS Trust
Bristol, BS10 5NB, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Nottingham University Hospitals
Nottingham, NG5 1PB, United Kingdom
Morriston Hospital
Swansea, SA66NL, United Kingdom
Related Publications (1)
St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PMID: 39356039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to discontinuation of all bardoxolone chronic kidney disease programs, study was terminated early.
Results Point of Contact
- Title
- US Biogen Clinical Trial Center
- Organization
- Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 17, 2019
Study Start
May 29, 2019
Primary Completion
August 8, 2023
Study Completion
August 8, 2023
Last Updated
June 3, 2025
Results First Posted
June 11, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/