A Trial of Bardoxolone Methyl in Patients with ADPKD (FALCON)
Overview
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:
● Current use of tolvaptan
● 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:
+1 469-442-4754
FALCON@reatapharma.com
Locations:
Alabama
University of Alabama at Birmingham
Birmingham, Alabama 35294
Principal Investigator: Dana Rizk, MD
Nephrology Consultants, LLC
Huntsville, Alabama 35805
Principal Investigator: Michael Quadrini, MD
Arizona
AKDHC
Glendale, Arizona 85306
Principal Investigator: Peter Santos, MD
Aventiv Research, Inc
Mesa, Arizona 85210
Principal Investigator: Mandeep Sahani, MD
University of Arizona
Tucson, Arizona 85719
Principal Investigator: Frank Brosius, MD
California
California Institute Renal Research
La Mesa, California 91942
Principal Investigator: George Fadda, MD
University of California, Los Angeles
Los Angeles, California 90025
Principal Investigator: Anjay Rastogi, MD
Amicis Research Center
Northridge, California, 91324
Principal Investigator: Dabel Pascal, MD
Apex Research of Riverside
Riverside, California 92505
Principal Investigator: Joseph Lee, MD
University of California, San Francisco
San Francisco, California, 94143
Principal Investigator: Meyeon Park, MD
Los Angeles, California, 90033
Principal Investigator: Nuria Pastor-Soler, MD
Colorado
Western Nephrology
Arvada, Colorado 80002
Principal Investigator: Harmeet Singh, MD
Connecticut
Yale University School of Medicine
New Haven, Connecticut 06520
Principal Investigator: Neera Dahl, MD
Florida
Volunteer Medical Research
Port Charlotte, Florida 33952
Principal Investigator: Kianoosh Kaveh, MD
Florida Premier Research Institute, LLC
Winter Park, Florida 32789
Principal Investigator: Jorge Kusnir, MD
Georgia
Atlanta, Georgia 30322
Principal Investigator: Frederic Rahbari-Oskoui, MD
Idaho
Boise Kidney & Hypertension, PLLC
Caldwell, Idaho 83605
Principal Investigator: Arnold Silva, MD
Boise Kidney & Hypertension, PLLC
Meridian, Idaho 83642
Principal Investigator: Arnold Silva, MD
Illinois
Chicago, Illinois 60611
Principal Investigator: Jennifer Tuazon, MD
Chicago, Illinois 60617
Principal Investigator: Arlene Chapman, MD
NorthShore University Health System
Evanston, Illinois 60201
Principal Investigator: Stuart Sprague, MD
Kansas
University of Kansas Medical Center
Kansas City, Kansas 66224
Principal Investigator: Kerri McGreal, MD
Kansas Nephrology Research Institute, LLC
Wichita, Kansas 67214
Principal Investigator: Dennis Ross, MD
Louisiana
Renal Associates of Baton Rouge
Baton Rouge, Louisiana 70808
Principal Investigator: Michael Roppolo, MD
Northwest Louisiana Nephrology
Shreveport, Louisiana 71101
Principal Investigator: Marwan Kaskas, MD
Maryland
University of Maryland School of Medicine
Baltimore, Maryland 21201
Principal Investigator: Stephen Seliger, MD
Massachusetts
Boston, Massachusetts 02111
Principal Investigator: Ronald Perrone, MD
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Principal Investigator: Theodore Steinman, MD
Michigan
Paragon Health PC d/b/a Nephrology Center PC
Kalamazoo, Michigan 49007
Principal Investigator: Than Oo, MD
Michigan Kidney Consultants
Pontiac, Michigan 48341
Principal Investigator: Fahd Al-Saghir, MD
Minnesota
Rochester, Minnesota 55905
Principal Investigator: Vicente Torres, MD
Missouri
Clinical Research Consultants, LLC
Kansas City, Missouri 64111
Principal Investigator: Ahmed Awad, MD
Washington University in St. Louis
Saint Louis, Missouri 63110
Principal Investigator: George Jarad, MD
New York
Nephrology Associates, P.C.
Flushing, New York 11355
Principal Investigator: Bruce Spinowitz, MD
North Carolina
Mountain Kidney & Hypertension Associates
Asheville, North Carolina 28801
Principal Investigator: Joseph Aiello, MD
Metrolina Nephrology Associates
Charlotte, North Carolina 28204
Principal Investigator: Peale Chuang, MD
Raleigh, North Carolina 27609
Principal Investigator: Jason Eckel, MD
Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio 45267
Principal Investigator: Kotagal Kant, MD
Cleveland, Ohio 44195
Principal Investigator: Richard Fatica, MD
Remington-Davis Clinical Research
Columbus, Ohio 43215
Principal Investigator: Kevin Schroeder, MD
Pennsylvania
Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017
Principal Investigator: Nelson Kopyt, MD
Philadelphia, Pennsylvania 19014
Principal Investigator: Simin Goral, MD
Children’s Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
Principal Investigator: Kevin Meyers, MD
South Carolina
Columbia Nephrology Associates, PA
Columbia, South Carolina 29203
Principal Investigator: Asha Bailey, MD
Tennessee
Nephrology Associates, P.C.
Nashville, Tennessee 37205
Principal Investigator: Douglas Linfert, MD
Texas
Research Management, Inc.
Austin, Texas 78751
Principal Investigator: Judith Betts, MD
Research Management, Inc.
Austin, Texas 78758
Principal Investigator: Eileen Cook, MD
Renal Disease Research Institute
Dallas, Texas 75235
Principal Investigator: Ankit Mehta, MD
DaVita Med Center
Houston, Texas 77004
Principal Investigator: Stephen Fadem, MD
Prolato Clinical Research Center
8990 Kirby Drive Suite 240/208
Houston TX 77054
Clinical Advancement Center
San Antonio, Texas 78215
Principal Investigator: Pablo Pergola, MD
Vermont
University of Vermont Medical Center
Burlington, Vermont 05401
Principal Investigator: Richard Solomon, MD
Virginia
Charlottesville, Virginia 22908
Principal Investigator: Sana Khan, MD
Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Principal Investigator: Ashraf El-Meanawy, MD
Australia: New South Wales, Queensland, South Australia, Victoria and Western Australia
United Kingdom: Cambridge and London