A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

PHASE3TerminatedINTERVENTIONAL
Enrollment

667

Participants

Timeline

Start Date

May 29, 2019

Primary Completion Date

August 8, 2023

Study Completion Date

August 8, 2023

Conditions
Autosomal Dominant Polycystic KidneyADPKD
Interventions
DRUG

Bardoxolone methyl oral capsule

Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.

DRUG

Placebo oral capsule

Capsule containing an inert placebo

Trial Locations (137)

168

Fondazione Policlinico Gemelli, Roma

1200

Nephrology, Cliniques U St-Luc, Brussels

2145

Westmead Hospital, Sydney

2250

Renal Research, Gosford

2305

John Hunter Hospital, New Lambton

3000

University Hospitals Leuven, Dept. of Nephrology, Dialysis and Renal Transplantation, Leuven

3050

Melbourne Health, Parkville

3073

Melbourne Renal Research Group, Reservoir

3168

Monash Health, Clayton

4000

Chu Liege, Liège

4029

Royal Brisbane and Women's Hospital, Herston

4575

Sunshine Coast University Hospital, Birtinya

5000

Royal Adelaide Hospital, Adelaide

6070

Hospital Universitario de Badajoz, Badajoz

6150

Fiona Stanley Hospital, Murdoch

8003

Hospital Del Mar, Barcelona

8025

Fundacio Puigvert, Barcelona

11021

Division of Kidney Diseases and Hypertension, Great Neck

11355

Nephrology Associates, P.C., Flushing

11501

NYU Winthrop Hospital, Mineola

12808

Nephrology Dept., General Teaching Hospital, Prague

14004

Hospital Universitario Reina Sofía, Córdoba

14021

IKEM, Prague

18012

Hospital Universitario Virgen de las Nieves, Granada

18017

Northeast Clinical Research Center, Bethlehem

19014

University of Pennsylvania, Philadelphia

19104

Children's Hospital of Philadelphia, Philadelphia

20153

Renal Division, ASST Santi Paolo e Carlo, Milan

21201

University of Maryland School of Medicine, Baltimore

21287

The Johns Hopkins University, Baltimore

22033

Nephrology Associates of Northern Virginia, Inc., Fairfax

22908

University of Virginia, Charlottesville

27003

Hospital Lucus Augusti, Lugo

27100

ICS Maugeri SpA SB, Pavia

27103

Brookview Hills Research Associates, LLC, Winston-Salem

27609

North Carolina Nephrology, P.A. 2nd Floor, Raleigh

28040

Fundación Jiménez Díaz, Madrid

28046

Hospital Universitario La Paz, Madrid

28204

Metrolina Nephrology Associates, Charlotte

28801

Mountain Kidney & Hypertension Associates, Asheville

28905

Hospital de Getafe, Madrid

29200

University Hospital La Cavale Blanche, Brest

29203

Columbia Nephrology Associates, PA, Columbia

30046

Georgia Nephrology, LLC, Lawrenceville

30322

Emory University, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

32789

Florida Premier Research Institute, LLC, Winter Park

33014

Pro-Care Research Center, Corp., Miami Gardens

33136

University of Miami, Miami

33157

Innovation Medical Research Center, Inc, Palmetto Bay

33606

University of South Florida, Tampa

33952

Volunteer Medical Research, Port Charlotte

34471

Discovery Medical Research Group, Ocala

35209

Nephrology Associates PC, Homewood

35294

University of Alabama at Birmingham, Birmingham

35805

Nephrology Consultants, LLC, Huntsville

37205

Nephrology Associates, P.C., Nashville

38043

Chu Grenoble Alpes, Grenoble

39008

Hospital Universitario Marques de Valdecilla, Santander

41124

Università di Modena e Reggio Emilia, Modena

43215

Remington-Davis Clinical Research, Columbus

44093

CHU de Nantes, Nantes

44195

Cleveland Clinic, Cleveland

45147

Universitätsklinikum Essen, Essen

45220

Cincinnati VA Medical Center, Cincinnati

45267

University of Cincinnati College of Medicine, Cincinnati

46017

Hospital Universitario Dr Peset, Valencia

48341

Michigan Kidney Consultants, Pontiac

49007

Paragon Health PC d/b/a Nephrology Center PC, Kalamazoo

53226

Medical College of Wisconsin, Milwaukee

Milwaukee Nephrologists, SC, Wauwatosa

55905

Mayo Clinic, Rochester

60153

Loyola University Chicago, Maywood

60611

Northwestern University, Chicago

60617

University of Chicago, Chicago

62500

FN Brno, Brno

63110

Washington University in St. Louis, St Louis

64111

Clinical Research Consultants, LLC, Kansas City

66224

University of Kansas Medical Center, Kansas City

66606

Cotton O'Neil Clinical Research Center, Topeka

67214

Ascension Via Christi Research, Wichita

Kansas Nephrology Research Institute, LLC, Wichita

70808

Renal Associates of Baton Rouge, Baton Rouge

71101

Northwest Louisiana Nephrology, Shreveport

75015

Hopital Necker, Universite Paris Descartes, Paris

75230

Liberty Research Center, Dallas

75235

Renal Disease Research Institute, Dallas

76015

Arlington Nephrology, PA, Arlington

77004

DaVita Med Center, Houston

78215

Clinical Advancement Center, San Antonio

78751

Research Management, Inc., Austin

78758

Research Management, Inc., Austin

79106

TTUHSC, Amarillo

79925

Davita Clinical Research, El Paso

80002

Western Nephrology, Arvada

80031

Western Nephrology and Mineral Bone Disease, PC, Westminster

80045

University of Colorado Anschutz Medical Center, Aurora

80210

Kidney Associates of Colorado, Denver

80230

Denver Nephrologist, PC, Denver

81675

Klinikum rechts der Isar der TU München, München

83605

Boise Kidney & Hypertension, PLLC, Caldwell

83642

Boise Kidney & Hypertension, PLLC, Meridian

85210

Aventiv Research, Inc, Mesa

85306

AKDHC, Glendale

85719

University of Arizona, Tucson

89129

KSOSN, Las Vegas

90025

University of California, Los Angeles, Los Angeles

90033

Keck USC/LAC, Los Angeles

90242

Rancho Research Institute, Downey

91324

Amicis Research Center, Northridge

91942

California Institute Renal Research, La Mesa

92505

Apex Research of Riverside, Riverside

94143

University of California San Francisco, San Francisco

94270

Hospital Henri-Mondor AP-HP, Le Kremlin-Bicêtre

94304

Stanford University, Palo Alto

98052

Swedish Medical Center, Seattle

06520

Yale University School of Medicine, New Haven

02111

Tufts Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01104

KidneyCare and Tranplant Services of New England, Springfield

01107

Renal and Transplant Associates of New England, PC, Springfield

05401

University of Vermont Medical Center, Burlington

B-1090

Universitair Ziekenhuis Brussel (VUB), Brussels

060-8648

Hokkaido University Hospital, Hokkaido

213-8587

Toranomon Hospital Kajigaya, Kanagawa

981-8501

Japan Community Healthcare Organization Sendai Hospital, Miyagi

951-8520

Niigata University Medical & Dental Hospital, Niigata

534-0021

Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital, Osaka

545-8586

Osaka City University Hospital, Osaka

565-0871

Osaka University Hospital, Osaka

105-8470

Toranomon Hospital, Tokyo

113-8431

Juntendo University Hospital, Tokyo

162-8666

Tokyo Women's Medical University Hospital, Tokyo

BS10 5NB

North Bristol NHS Trust, Bristol

M13 9WL

Manchester University NHS Foundation Trust, Manchester

NG5 1PB

Nottingham University Hospitals, Nottingham

SA66NL

Morriston Hospital, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY