FALCON is a Phase 3 clinical study evaluating the effectiveness and safety of bardoxolone methyl (an oral investigational drug) in patients with Autosomal Dominant PKD.
Before participating in FALCON, patients must complete two screening visits at one of the study centers. Eligible patients will be randomly assigned (like the flip of a coin) to receive either bardoxolone methyl or placebo (an inactive capsule). The group of patients assigned to bardoxolone methyl will be compared to the group of patients assigned to placebo in order to help researchers better understand the effects on PKD.
The investigational drug, study-related procedures and doctor visits will be provided at no cost. If you travel to the site for your study visits, travel expenses will be reimbursed and compensation for study-related time may be compensated.
You may be eligible for this study if you:
● Are between 18 to 70 years of age
● Have been diagnosed with ADPKD
● Have a lab value eGFR between 30 to 90 mL/min/1.73 m2 (18 to 55 years old) or between 30 to 44 mL/min/1.73 m2 (56 to 70 years old)
Exclusion Criteria:
● Uncontrolled diabetes;
● History of intracranial aneurysms;
● Kidney or any other solid organ transplant recipient or a planned transplant during the study;
● Systemic immunosuppression for more than 2 weeks or anticipated need for immunosuppression during the study;
● Women who are pregnant or breastfeeding;
If you’re interested in participating, contact the Study Manager at:
+1 469-442-4754
FALCON@reatapharma.com
Locations:
Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Principal Investigator: Dana Rizk, MD
Nephrology Consultants, LLC
Huntsville, Alabama, United States, 35805
Principal Investigator: Michael Quadrini, MD
Arizona
AKDHC
Glendale, Arizona, United States, 85306
Principal Investigator: Peter Santos, MD
Aventiv Research, Inc
Mesa, Arizona, United States, 85210
Principal Investigator: Mandeep Sahani, MD
University of Arizona
Tucson, Arizona, United States, 85719
Principal Investigator: Frank Brosius, MD
California
California Institute Renal Research
La Mesa, California, United States, 91942
Principal Investigator: George Fadda, MD
University of California, Los Angeles
Los Angeles, California, United States, 90025
Principal Investigator: Anjay Rastogi, MD
Apex Research of Riverside
Riverside, California, United States, 92505
Principal Investigator: Joseph Lee, MD
Colorado
Western Nephrology
Arvada, Colorado, United States, 80002
Principal Investigator: Harmeet Singh, MD
Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Principal Investigator: Neera Dahl, MD
Florida
Volunteer Medical Research
Port Charlotte, Florida, United States, 33952
Principal Investigator: Kianoosh Kaveh, MD
Florida Premier Research Institute, LLC
Winter Park, Florida, United States, 32789
Principal Investigator: Jorge Kusnir, MD
Georgia
Emory University
Atlanta, Georgia, United States, 30322
Principal Investigator: Frederic Rahbari-Oskoui, MD
Idaho
Boise Kidney & Hypertension, PLLC
Caldwell, Idaho, United States, 83605
Principal Investigator: Arnold Silva, MD
Boise Kidney & Hypertension, PLLC
Meridian, Idaho, United States, 83642
Principal Investigator: Arnold Silva, MD
Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Principal Investigator: Jennifer Tuazon, MD
University of Chicago
Chicago, Illinois, United States, 60617
Principal Investigator: Arlene Chapman, MD
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Principal Investigator: Stuart Sprague, MD
Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66224
Principal Investigator: Kerri McGreal, MD
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, United States, 67214
Principal Investigator: Dennis Ross, MD
Louisiana
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States, 70808
Principal Investigator: Michael Roppolo, MD
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States, 71101
Principal Investigator: Marwan Kaskas, MD
Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Principal Investigator: Stephen Seliger, MD
Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Principal Investigator: Ronald Perrone, MD
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Principal Investigator: Theodore Steinman, MD
Michigan
Paragon Health PC d/b/a Nephrology Center PC
Kalamazoo, Michigan, United States, 49007
Principal Investigator: Than Oo, MD
Michigan Kidney Consultants
Pontiac, Michigan, United States, 48341
Principal Investigator: Fahd Al-Saghir, MD
Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Principal Investigator: Vicente Torres, MD
Missouri
Clinical Research Consultants, LLC
Kansas City, Missouri, United States, 64111
Principal Investigator: Ahmed Awad, MD
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Principal Investigator: George Jarad, MD
New York
Nephrology Associates, P.C.
Flushing, New York, United States, 11355
Principal Investigator: Bruce Spinowitz, MD
North Carolina
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, United States, 28801
Principal Investigator: Joseph Aiello, MD
Metrolina Nephrology Associates
Charlotte, North Carolina, United States, 28204
Principal Investigator: Peale Chuang, MD
Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
Principal Investigator: Kotagal Kant, MD
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Principal Investigator: Richard Fatica, MD
Remington-Davis Clinical Research
Columbus, Ohio, United States, 43215
Principal Investigator: Kevin Schroeder, MD
Pennsylvania
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States, 18017
Principal Investigator: Nelson Kopyt, MD
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19014
Principal Investigator: Simin Goral, MD
Children’s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Kevin Meyers, MD
South Carolina
Columbia Nephrology Associates, PA
Columbia, South Carolina, United States, 29203
Principal Investigator: Asha Bailey, MD
Tennessee
Nephrology Associates, P.C.
Nashville, Tennessee, United States, 37205
Principal Investigator: Douglas Linfert, MD
Texas
Research Management, Inc.
Austin, Texas, United States, 78751
Principal Investigator: Judith Betts, MD
Research Management, Inc.
Austin, Texas, United States, 78758
Principal Investigator: Eileen Cook, MD
Renal Disease Research Institute
Dallas, Texas, United States, 75235
Principal Investigator: Ankit Mehta, MD
DaVita Med Center
Houston, Texas, United States, 77004
Principal Investigator: Stephen Fadem, MD
Clinical Advancement Center
San Antonio, Texas, United States, 78215
Principal Investigator: Pablo Pergola, MD
Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Principal Investigator: Richard Solomon, MD
Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Principal Investigator: Sana Khan, MD
Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: Ashraf El-Meanawy, MD
Australia: New South Wales, Queensland, South Australia, Victoria and Western Australia
Belgium: Brussels and Leuven
Czechia: Brno, Prague and Praha
France: Brest and Grenoble
Germany: Erlangen, Essen, Hanover and München
Italy: Milan and Napoli
Spain: Barcelona and Madrid
United Kingdom: Cambridge and London