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A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON (FALCON)

Primary Purpose

Autosomal Dominant Polycystic Kidney, ADPKD

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bardoxolone methyl oral capsule
Placebo oral capsule
Sponsored by
Reata Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney focused on measuring Bardoxolone Methyl, RTA 402, Autosomal Dominant Polycystic Kidney Disease, ADPKD

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients 12 ≤ age ≤ 70 upon study consent;
  • Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history;

  • Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years):

    1) 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 visit after a period of rest.

Exclusion Criteria:

  • History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 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;
  • Women who are pregnant or breastfeeding;
  • Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 3 months prior to Screen A visit

Sites / Locations

  • University of Alabama at Birmingham
  • Nephrology Associates PC
  • Nephrology Consultants, LLC
  • AKDHC
  • Aventiv Research, Inc
  • University of Arizona
  • Rancho Research Institute
  • California Institute Renal Research
  • University of California, Los Angeles
  • Keck USC/LAC
  • Amicis Research Center
  • Stanford University
  • Apex Research of Riverside
  • University of California San Francisco
  • Western Nephrology
  • University of Colorado Anschutz Medical Center
  • Kidney Associates of Colorado
  • Denver Nephrologist, PC
  • Western Nephrology and Mineral Bone Disease, PC
  • Yale University School of Medicine
  • Pro-Care Research Center, Corp.
  • University of Miami
  • Discovery Medical Research Group
  • Innovation Medical Research Center, Inc
  • Volunteer Medical Research
  • University of South Florida
  • Florida Premier Research Institute, LLC
  • Emory University
  • Georgia Nephrology, LLC
  • Boise Kidney & Hypertension, PLLC
  • Boise Kidney & Hypertension, PLLC
  • Northwestern University
  • University of Chicago
  • Loyola University Chicago
  • University of Kansas Medical Center
  • Cotton O'Neil Clinical Research Center
  • Ascension Via Christi Research
  • Kansas Nephrology Research Institute, LLC
  • Renal Associates of Baton Rouge
  • Northwest Louisiana Nephrology
  • University of Maryland School of Medicine
  • The Johns Hopkins University
  • Tufts Medical Center
  • Beth Israel Deaconess Medical Center
  • KidneyCare and Tranplant Services of New England
  • Renal and Transplant Associates of New England, PC
  • Paragon Health PC d/b/a Nephrology Center PC
  • Michigan Kidney Consultants
  • Mayo Clinic
  • Clinical Research Consultants, LLC
  • Washington University in St. Louis
  • KSOSN
  • Nephrology Associates, P.C.
  • Division of Kidney Diseases and Hypertension
  • NYU Winthrop Hospital
  • Mountain Kidney & Hypertension Associates
  • Metrolina Nephrology Associates
  • North Carolina Nephrology, P.A. 2nd Floor
  • Brookview Hills Research Associates, LLC
  • Cincinnati VA Medical Center
  • University of Cincinnati College of Medicine
  • Cleveland Clinic
  • Remington-Davis Clinical Research
  • Northeast Clinical Research Center
  • University of Pennsylvania
  • Children's Hospital of Philadelphia
  • Columbia Nephrology Associates, PA
  • Nephrology Associates, P.C.
  • TTUHSC
  • Arlington Nephrology, PA
  • Research Management, Inc.
  • Research Management, Inc.
  • Liberty Research Center
  • Renal Disease Research Institute
  • Davita Clinical Research
  • DaVita Med Center
  • Clinical Advancement Center
  • University of Vermont Medical Center
  • University of Virginia
  • Nephrology Associates of Northern Virginia, Inc.
  • Swedish Medical Center
  • Medical College of Wisconsin
  • Milwaukee Nephrologists, SC
  • Renal Research
  • John Hunter Hospital
  • Westmead Hospital
  • Sunshine Coast University Hospital
  • Royal Brisbane and Women's Hospital
  • Royal Adelaide Hospital
  • Monash Health
  • Melbourne Health
  • Melbourne Renal Research Group
  • Fiona Stanley Hospital
  • Nephrology, Cliniques U St-Luc
  • Universitair Ziekenhuis Brussel (VUB)
  • University Hospitals Leuven, Dept. of Nephrology, Dialysis and Renal Transplantation
  • Chu Liege
  • FN Brno
  • Nephrology Dept., General Teaching Hospital
  • IKEM
  • University Hospital La Cavale Blanche
  • Chu Grenoble Alpes
  • Hospital Henri-Mondor AP-HP
  • CHU de Nantes
  • Hopital Necker, Universite Paris Descartes
  • Universitätsklinikum Essen
  • Medizinische Hochschule Hannover
  • Klinikum rechts der Isar der TU München
  • Renal Division, ASST Santi Paolo e Carlo
  • Università di Modena e Reggio Emilia
  • ICS Maugeri SpA SB
  • Fondazione Policlinico Gemelli
  • Hokkaido University Hospital
  • Toranomon Hospital Kajigaya
  • Japan Community Healthcare Organization Sendai Hospital
  • Niigata University Medical & Dental Hospital
  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
  • Osaka City University Hospital
  • Osaka University Hospital
  • Toranomon Hospital
  • Juntendo University Hospital
  • Tokyo Women's Medical University Hospital
  • Hospital Universitario de Badajoz
  • Hospital Del Mar
  • Fundacio Puigvert
  • Hospital Universitario Reina Sofía
  • Hospital Universitario Virgen de las Nieves
  • Hospital Lucus Augusti
  • Fundación Jiménez Díaz
  • Hospital Universitario La Paz
  • Hospital de Getafe
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario Dr Peset
  • North Bristol NHS Trust
  • Manchester University NHS Foundation Trust
  • Nottingham University Hospitals
  • Morriston Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Maximum bardoxolone methyl dose of 20 mg

Maximum bardoxolone methyl dose 30 mg

Placebo

Arm Description

Patients 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.

Patients 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.

Patients 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.

Outcomes

Primary Outcome Measures

Change in eGFR from baseline (108 weeks)
To assess the off-treatment change from baseline in estimated glomerular filtration rate (eGFR) at Week 108 for patients receiving active drug, compared to patients receiving placebo.
Count of reported adverse events
Safety and tolerability will be assessed by counting adverse events, as defined by the Medical Dictionary for Regulatory Activities (MedDRA)

Secondary Outcome Measures

Change in eGFR from baseline (100 weeks)
To assess the off-treatment change from baseline in eGFR at Week 100, for patients receiving active drug, compared to patients receiving placebo.

Full Information

First Posted
April 12, 2019
Last Updated
June 1, 2023
Sponsor
Reata Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03918447
Brief Title
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
Acronym
FALCON
Official Title
A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Discontinuation of all bardoxolone chronic kidney disease programs
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reata Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Patients will be randomized 1:1 to either bardoxolone methyl or placebo. Patients receiving bardoxolone methyl will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2, to 20 mg at Week 4, and then to 30 mg at Week 6 (only if baseline ACR >300 mg/g) unless contraindicated clinically and approved by the medical monitor. Dose de-escalation is permitted during the study if indicated clinically, and subsequent dose re-escalation is also permitted to meet the dosing objective of the highest tolerated dose. All patients in the study will follow the same visit and assessment schedule. Patients will continue to receive study drug or placebo through Week 100 and will not receive study drug or placebo during a 12-week off-treatment period between Weeks 100 and 112.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney, ADPKD
Keywords
Bardoxolone Methyl, RTA 402, Autosomal Dominant Polycystic Kidney Disease, ADPKD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maximum bardoxolone methyl dose of 20 mg
Arm Type
Experimental
Arm Description
Patients 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.
Arm Title
Maximum bardoxolone methyl dose 30 mg
Arm Type
Experimental
Arm Description
Patients 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients 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.
Intervention Type
Drug
Intervention Name(s)
Bardoxolone methyl oral capsule
Other Intervention Name(s)
RTA 402
Intervention Description
Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Capsule containing an inert placebo
Primary Outcome Measure Information:
Title
Change in eGFR from baseline (108 weeks)
Description
To assess the off-treatment change from baseline in estimated glomerular filtration rate (eGFR) at Week 108 for patients receiving active drug, compared to patients receiving placebo.
Time Frame
108 weeks
Title
Count of reported adverse events
Description
Safety and tolerability will be assessed by counting adverse events, as defined by the Medical Dictionary for Regulatory Activities (MedDRA)
Time Frame
112 weeks
Secondary Outcome Measure Information:
Title
Change in eGFR from baseline (100 weeks)
Description
To assess the off-treatment change from baseline in eGFR at Week 100, for patients receiving active drug, compared to patients receiving placebo.
Time Frame
100 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients 12 ≤ age ≤ 70 upon study consent; Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history; Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years): 1) 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 visit after a period of rest. Exclusion Criteria: History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 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; Women who are pregnant or breastfeeding; Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 3 months prior to Screen A visit
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Nephrology Associates PC
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Nephrology Consultants, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
AKDHC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Aventiv Research, Inc
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Rancho Research Institute
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
California Institute Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Keck USC/LAC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Amicis Research Center
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Western Nephrology
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
University of Colorado Anschutz Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Kidney Associates of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Denver Nephrologist, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Western Nephrology and Mineral Bone Disease, PC
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Pro-Care Research Center, Corp.
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Discovery Medical Research Group
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Innovation Medical Research Center, Inc
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Volunteer Medical Research
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Florida Premier Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Nephrology, LLC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Boise Kidney & Hypertension, PLLC
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Boise Kidney & Hypertension, PLLC
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60617
Country
United States
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66224
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Ascension Via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Kansas Nephrology Research Institute, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Renal Associates of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Northwest Louisiana Nephrology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
KidneyCare and Tranplant Services of New England
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Renal and Transplant Associates of New England, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Paragon Health PC d/b/a Nephrology Center PC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Michigan Kidney Consultants
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
KSOSN
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Division of Kidney Diseases and Hypertension
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Mountain Kidney & Hypertension Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Metrolina Nephrology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
North Carolina Nephrology, P.A. 2nd Floor
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Brookview Hills Research Associates, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Remington-Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Northeast Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19014
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Columbia Nephrology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
TTUHSC
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Arlington Nephrology, PA
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Research Management, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Research Management, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Liberty Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Renal Disease Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Davita Clinical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
DaVita Med Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Clinical Advancement Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Nephrology Associates of Northern Virginia, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98052
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Milwaukee Nephrologists, SC
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Renal Research
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Melbourne Health
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Melbourne Renal Research Group
City
Reservoir
State/Province
Victoria
ZIP/Postal Code
3073
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Nephrology, Cliniques U St-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel (VUB)
City
Brussels
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
University Hospitals Leuven, Dept. of Nephrology, Dialysis and Renal Transplantation
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Chu Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
FN Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Nephrology Dept., General Teaching Hospital
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
IKEM
City
Praha
ZIP/Postal Code
14021
Country
Czechia
Facility Name
University Hospital La Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Chu Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hospital Henri-Mondor AP-HP
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Necker, Universite Paris Descartes
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Renal Division, ASST Santi Paolo e Carlo
City
Milan
ZIP/Postal Code
20153
Country
Italy
Facility Name
Università di Modena e Reggio Emilia
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
ICS Maugeri SpA SB
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Policlinico Gemelli
City
Roma
ZIP/Postal Code
168
Country
Italy
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Toranomon Hospital Kajigaya
City
Kanagawa
ZIP/Postal Code
213-8587
Country
Japan
Facility Name
Japan Community Healthcare Organization Sendai Hospital
City
Miyagi
ZIP/Postal Code
981-8501
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Hospital Universitario de Badajoz
City
Badajoz
ZIP/Postal Code
6070
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Fundacio Puigvert
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Hospital Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital de Getafe
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Dr Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
North Bristol NHS Trust
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Nottingham University Hospitals
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA66NL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

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