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A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL (CARDINAL)

Primary Purpose

Alport Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo Oral Capsule
Bardoxolone Methyl
Sponsored by
Reata Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alport Syndrome focused on measuring Alport Syndrome, Bardoxolone methyl, CDDO-ME, RTA 402

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients 12 ≤ age ≤ 60 upon study consent;
  • Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or COL4A5) or histologic assessment using electron microscopy;
  • Screening eGFR ≥ 30 and ≤ 90 mL/min/1.73 m2. 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) ≤ 3500 mg/g at Screen B visit;
  • If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB), the medications must remain the same for at least 6 weeks prior to the Screen A visit and during Screening. The dosage of ACE inhibitor and/or ARB must also be stable for 2 weeks prior to the Screen A visit and remain the same through Day 1 (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to the Screen A visit;
  • Adequate bone marrow reserve and organ function at the Screen A visit
  • Able to swallow capsules;
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;

Exclusion Criteria:

  • Prior exposure to bardoxolone methyl;
  • Ongoing chronic hemodialysis or peritoneal dialysis therapy;
  • Renal transplant recipient;
  • B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
  • Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit;
  • Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
  • Serum albumin < 3 g/dL at Screen A visit;
  • History of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
  • Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Screen A visit after a period of rest;
  • Systolic BP < 90 mm Hg at Screen A visit after a period of rest;
  • 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;
  • Known hypersensitivity to any component of the study drug

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Kidney Disease and Hypertension Research Services, PLLC
  • Scripps Clinic, Nephrology
  • Academic Medical Research Institute
  • David Geffen School of Medicine at UCLA
  • General Clinical Research Center - Parnassus
  • University of California San Francisco - Children's Renal Center
  • Denver Nephrologists PC
  • South Florida Research Institute
  • Emory University School of Medicine and Children's Healthcare of Atlanta
  • Boise Kidney & Hypertension Institute
  • Boise Kidney & Hypertension Institute
  • NorthShore University Health System
  • Biolab Research, LLC
  • Tufts Medical Center
  • University of Michigan
  • University of Minnesota - Division of Pediatric Nephrology
  • Children's Research Institute - The Children's Mercy Hospital
  • Washington University School of Medicine
  • Hackensack Meridian School of Medicine
  • Nephrology Associates, PC
  • Columbia University Nephrology
  • Duke University Medical Center
  • Brookview Hills Research Associates, PLLC
  • Akron Nephrology Associates
  • Akron Children's Hospital
  • University of Cincinnati
  • Cleveland Clinic
  • Oregon Health & Science University
  • Children's Hospital of Philadelphia (CHOP)
  • University of Pittsburgh School of Medicine - Division of Pediatric Nephrology
  • The Warren Alpert Medical School of Brown University
  • South Carolina Nephrology & Hypertension Center, Inc
  • Renal Disease Research Institute
  • Southwest Houston Research
  • Clinical Advancement Center
  • University of Utah Health
  • Advanced Clinical Research
  • Royal Brisbane and Women's Hospital
  • Melbourne Renal Research Group
  • John Hunter Hospital
  • Sydney Children's Hospital
  • The Children's Hospital at Westmead
  • CHU Grenoble- Grenoble France
  • CHU Lyon-Hopital Edouard Herriot
  • Hopital Necker-Universite Paris Descartes
  • University of Medicine Gottingen
  • University Children's Hospital Heidelberg
  • St Marianna University Hospital
  • Kobe University Hospital
  • Japanese Red Cross Nagoya Daini Hospital
  • JCHO Cyukyo Hospital
  • Kitano Hospital
  • Saga University Hospital
  • Saitama Children's Medical Center
  • JCHO Sendai Hospital
  • Juntendo University Hospital
  • Tokyo Metropolitan Children's Medical Center
  • Puerto Rico Clinical & Translational Research Center
  • Servicio de Nefrologia pediatrica
  • Fundacio Puigvert
  • Hospital Virgen de la Arrixaca
  • Royal Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Phase 2 Bardoxolone Methyl

Phase 3 Bardoxolone Methyl

Phase 3 Placebo

Arm Description

Patients in the Phase 2 cohort will receive bardoxolone methyl throughout the study. Patients with baseline ACR ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline ACR > 300 mg/g will be titrated to a maximum dose of 30 mg. Adult patients (≥ 18 years of age) 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. Patients under the age of 18 receiving bardoxolone methyl will start 5 mg every other day during the first week and begin once-daily dosing with 5 mg during the second week of the study, and then continue with once-daily dosing following the same aforementioned dose titration scheme based on baseline ACR at Weeks 2, 4, and 6.

Patients with baseline ACR ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline ACR > 300 mg/g will be titrated to a maximum dose of 30 mg. Adult patients (≥ 18 years of age) 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. Patients under the age of 18 receiving bardoxolone methyl will start 5 mg every other day during the first week and begin once-daily dosing with 5 mg during the second week of the study, and then continue with once-daily dosing following the same aforementioned dose titration scheme based on baseline ACR at Weeks 2, 4, and 6.

Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration.

Outcomes

Primary Outcome Measures

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks of Treatment (Phase 2)
To assess the change in eGFR from baseline to week 12 (Phase 2). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Change From Baseline in eGFR After 48 Weeks of Treatment (Phase 3)
To assess the change in eGFR from baseline to week 48 (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Change From Baseline in eGFR After 100 Weeks of Treatment (Phase 3)
To assess the change in eGFR from baseline to week 100 (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.

Secondary Outcome Measures

Change From Baseline in eGFR After 48 Weeks of Treatment (Phase 2)
To assess the change from baseline in eGFR in bardoxolone methyl-treated patients at Week 48. Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Change From Baseline in eGFR After 100 Weeks of Treatment (Phase 2)
To assess the change from baseline in eGFR in bardoxolone methyl-treated patients at Week 100. Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Change From Baseline in eGFR at Week 52 Following a 4-week Drug Treatment Withdrawal Period (Phase 3)
To assess the change in eGFR from baseline to week 52 following a 4-week drug treatment withdrawal period (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Change From Baseline in eGFR at Week 104 Following a 4-week Drug Treatment Withdrawal Period (Phase 3)
To assess the change in eGFR from baseline to week 104 following a 4-week drug treatment withdrawal period (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.

Full Information

First Posted
January 6, 2017
Last Updated
September 18, 2023
Sponsor
Reata Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03019185
Brief Title
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
Acronym
CARDINAL
Official Title
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
October 6, 2020 (Actual)
Study Completion Date
October 30, 2020 (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, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.
Detailed Description
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients. Patients in the Phase 2 cohort will receive bardoxolone methyl throughout the study. Patients in the Phase 3 cohort will be randomized 1:1 to either bardoxolone methyl or placebo and randomization will be stratified by baseline albumin to creatinine ratio (ACR). Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration. All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, 12, 24, 36, 48, 52, 64, 76, 88, 100, and 104 and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will not receive study drug during a 4-week withdrawal period between Weeks 48 and 52. They will re-start treatment at Week 52 at the same dose they received at Week 48 and will continue study drug treatment through Week 100. Patients will also be scheduled to be assessed at an in person follow up visit at Week 104, four weeks after the end of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alport Syndrome
Keywords
Alport Syndrome, Bardoxolone methyl, CDDO-ME, RTA 402

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 Bardoxolone Methyl
Arm Type
Experimental
Arm Description
Patients in the Phase 2 cohort will receive bardoxolone methyl throughout the study. Patients with baseline ACR ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline ACR > 300 mg/g will be titrated to a maximum dose of 30 mg. Adult patients (≥ 18 years of age) 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. Patients under the age of 18 receiving bardoxolone methyl will start 5 mg every other day during the first week and begin once-daily dosing with 5 mg during the second week of the study, and then continue with once-daily dosing following the same aforementioned dose titration scheme based on baseline ACR at Weeks 2, 4, and 6.
Arm Title
Phase 3 Bardoxolone Methyl
Arm Type
Active Comparator
Arm Description
Patients with baseline ACR ≤ 300 mg/g will be titrated to a maximum dose of 20 mg, and patients with baseline ACR > 300 mg/g will be titrated to a maximum dose of 30 mg. Adult patients (≥ 18 years of age) 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. Patients under the age of 18 receiving bardoxolone methyl will start 5 mg every other day during the first week and begin once-daily dosing with 5 mg during the second week of the study, and then continue with once-daily dosing following the same aforementioned dose titration scheme based on baseline ACR at Weeks 2, 4, and 6.
Arm Title
Phase 3 Placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Capsule
Intervention Description
Capsule containing an inert placebo
Intervention Type
Drug
Intervention Name(s)
Bardoxolone Methyl
Other Intervention Name(s)
RTA 402
Intervention Description
Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.
Primary Outcome Measure Information:
Title
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks of Treatment (Phase 2)
Description
To assess the change in eGFR from baseline to week 12 (Phase 2). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Time Frame
Baseline through 12 weeks after participant receives the first dose in the Phase 2 study
Title
Change From Baseline in eGFR After 48 Weeks of Treatment (Phase 3)
Description
To assess the change in eGFR from baseline to week 48 (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Time Frame
Baseline through 48 weeks after participant receives the first dose in the Phase 3 study
Title
Change From Baseline in eGFR After 100 Weeks of Treatment (Phase 3)
Description
To assess the change in eGFR from baseline to week 100 (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Time Frame
Baseline through 100 weeks after participant receives the first dose in the Phase 3 study
Secondary Outcome Measure Information:
Title
Change From Baseline in eGFR After 48 Weeks of Treatment (Phase 2)
Description
To assess the change from baseline in eGFR in bardoxolone methyl-treated patients at Week 48. Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Time Frame
Baseline through 48 weeks after participant receives the first dose in the Phase 2 study
Title
Change From Baseline in eGFR After 100 Weeks of Treatment (Phase 2)
Description
To assess the change from baseline in eGFR in bardoxolone methyl-treated patients at Week 100. Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Time Frame
Baseline through 100 weeks after participant receives the first dose in the Phase 2 study
Title
Change From Baseline in eGFR at Week 52 Following a 4-week Drug Treatment Withdrawal Period (Phase 3)
Description
To assess the change in eGFR from baseline to week 52 following a 4-week drug treatment withdrawal period (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Time Frame
Baseline through 52 weeks after participant receives the first dose in the Phase 3 study (or 4 weeks after last dose for patients who discontinued early in the first year)
Title
Change From Baseline in eGFR at Week 104 Following a 4-week Drug Treatment Withdrawal Period (Phase 3)
Description
To assess the change in eGFR from baseline to week 104 following a 4-week drug treatment withdrawal period (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Time Frame
Baseline through 104 weeks after participant receives the first dose in the Phase 3 study (or 4 weeks after last dose for patients who discontinued early in the second year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients 12 ≤ age ≤ 60 upon study consent; Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or COL4A5) or histologic assessment using electron microscopy; Screening eGFR ≥ 30 and ≤ 90 mL/min/1.73 m2. 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) ≤ 3500 mg/g at Screen B visit; If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB), the medications must remain the same for at least 6 weeks prior to the Screen A visit and during Screening. The dosage of ACE inhibitor and/or ARB must also be stable for 2 weeks prior to the Screen A visit and remain the same through Day 1 (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to the Screen A visit; Adequate bone marrow reserve and organ function at the Screen A visit Able to swallow capsules; Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; Exclusion Criteria: Prior exposure to bardoxolone methyl; Ongoing chronic hemodialysis or peritoneal dialysis therapy; Renal transplant recipient; B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit; Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit; Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening; Serum albumin < 3 g/dL at Screen A visit; History of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following: Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Screen A visit after a period of rest; Systolic BP < 90 mm Hg at Screen A visit after a period of rest; 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; Known hypersensitivity to any component of the study drug
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Kidney Disease and Hypertension Research Services, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Scripps Clinic, Nephrology
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
General Clinical Research Center - Parnassus
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of California San Francisco - Children's Renal Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Denver Nephrologists PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
South Florida Research Institute
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Emory University School of Medicine and Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Boise Kidney & Hypertension Institute
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Boise Kidney & Hypertension Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Biolab Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota - Division of Pediatric Nephrology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Children's Research Institute - The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack Meridian School of Medicine
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Nephrology Associates, PC
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Columbia University Nephrology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
Brookview Hills Research Associates, PLLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Akron Nephrology Associates
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Philadelphia (CHOP)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh School of Medicine - Division of Pediatric Nephrology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The Warren Alpert Medical School of Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
South Carolina Nephrology & Hypertension Center, Inc
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Renal Disease Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Southwest Houston Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
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 Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
2145
Country
Australia
Facility Name
Melbourne Renal Research Group
City
Melbourne
ZIP/Postal Code
VIC 3073
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
ZIP/Postal Code
NSW 2305
Country
Australia
Facility Name
Sydney Children's Hospital
City
Sydney
ZIP/Postal Code
NSW 2031
Country
Australia
Facility Name
The Children's Hospital at Westmead
City
Westmead
ZIP/Postal Code
NSW 2145
Country
Australia
Facility Name
CHU Grenoble- Grenoble France
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
CHU Lyon-Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hopital Necker-Universite Paris Descartes
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
University of Medicine Gottingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
University Children's Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
St Marianna University Hospital
City
Kawasaki
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya
Country
Japan
Facility Name
JCHO Cyukyo Hospital
City
Nagoya
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
Country
Japan
Facility Name
Saga University Hospital
City
Saga
Country
Japan
Facility Name
Saitama Children's Medical Center
City
Saitama
Country
Japan
Facility Name
JCHO Sendai Hospital
City
Sendai
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Metropolitan Children's Medical Center
City
Tokyo
Country
Japan
Facility Name
Puerto Rico Clinical & Translational Research Center
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Servicio de Nefrologia pediatrica
City
Barcelona
ZIP/Postal Code
119-08035
Country
Spain
Facility Name
Fundacio Puigvert
City
Barcelona
ZIP/Postal Code
340-08025
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33789284
Citation
Chertow GM, Appel GB, Andreoli S, Bangalore S, Block GA, Chapman AB, Chin MP, Gibson KL, Goldsberry A, Iijima K, Inker LA, Knebelmann B, Mariani LH, Meyer CJ, Nozu K, O'Grady M, Silva AL, Stenvinkel P, Torra R, Warady BA, Pergola PE. Study Design and Baseline Characteristics of the CARDINAL Trial: A Phase 3 Study of Bardoxolone Methyl in Patients with Alport Syndrome. Am J Nephrol. 2021;52(3):180-189. doi: 10.1159/000513777. Epub 2021 Mar 31.
Results Reference
derived
PubMed Identifier
33159213
Citation
Kashtan CE, Gross O. Clinical practice recommendations for the diagnosis and management of Alport syndrome in children, adolescents, and young adults-an update for 2020. Pediatr Nephrol. 2021 Mar;36(3):711-719. doi: 10.1007/s00467-020-04819-6. Epub 2020 Nov 6. Erratum In: Pediatr Nephrol. 2021 Jan 12;:
Results Reference
derived
Links:
URL
https://www.cardinalclinicaltrial.com/
Description
Website for the CARDINAL study

Learn more about this trial

A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL

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