An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease

Who is this study for? Child to adult patients with End Stage Kidney Disease or Nephrotic Syndrome
What treatments are being studied? Bardoxolone
Status: Terminated
Location: See all (87) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial.

• Meets the following eligibility criteria based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable:

‣ Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with eGFR \<20 ml/min/1.73m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline \> 1.0 ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not be eligible);

⁃ BNP \< 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable;

⁃ No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable.

• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

• Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Apogee Clinical Research
Huntsville
Arizona
Arizona Kidney Disease and Hypertension Research Services, PLLC
Glendale
Centricity Research Phoenix Multispecialty
Mesa
California
California Institute Renal Research
La Mesa
Academic Medical Research Institute
Los Angeles
David Geffen School of Medicine at UCLA
Los Angeles
Apex Research of Riverside
Riverside
Rady Children's Hospital - San Diego
San Diego
University of California San Francisco - Children's Renal Center
San Francisco
University of California, San Francisco
San Francisco
Colorado
Western Nephrology
Arvada
University of Colorado Anschutz Medical Center
Aurora
Colorado Kidney Care, PC
Denver
Florida
South Florida Research Institute
Lauderdale Lakes
Innovation Medical Research, Inc.
Palmetto Bay
USF Health South Tampa Center
Tampa
Florida Premier Research Institute, LLC
Winter Park
Georgia
Emory University School of Medicine
Atlanta
Idaho
Boise Kidney & Hypertension, PLLC
Caldwell
Boise Kidney & Hypertension, PLLC
Meridian
Illinois
Northwestern University
Chicago
Nephrology Research NorthShore University Health System
Evanston
Kansas
University of Kansas Medical Center
Kansas City
Louisiana
Renal Associates of Baton Rouge
Baton Rouge
Northwest Louisiana Nephrology
Shreveport
Massachusetts
Tufts Medical Center
Boston
Tufts Medical Center - Division of Nephrology
Boston
Maryland
The Johns Hopkins University
Baltimore
Michigan
University of Michigan
Ann Arbor
Nephrology Center, PC
Kalamazoo
Minnesota
Mayo Clinic
Rochester
Missouri
Children's Mercy Hospital and Clinics
Kansas City
Clinical Research Consultants, LLC
Kansas City
Washington University School of Medicine
St Louis
North Carolina
Mountain Kidney & Hypertension Associates
Asheville
North Carolina Nephrology
Cary
Metrolina Nephrology Associates
Charlotte
Duke University Medical Center
Durham
Metrolina Nephrology Associates
Gastonia
New Jersey
Hackensack University Medical Center
Hackensack
Nevada
KSOSN
Las Vegas
New York
Columbia University Medical Center
New York
Ohio
Cleveland Clinic
Cleveland
Remington-Davis Clinical Research
Columbus
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Northeast Clinical Research Center
Bethlehem
Children's Hospital of Philadelphia
Philadelphia
UPMC Children's Hospital of Pittsburgh
Pittsburgh
South Carolina
Columbia Nephrology Associates, PA
Columbia
South Carolina Nephrology & Hypertension Center, Inc
Orangeburg
Texas
Arlington Nephrology
Arlington
Research Management, Inc.
Austin
Renal Disease Research Institute
Dallas
DaVita Med Center
Houston
Southwest Houston Research
Houston
Clinical Advancement Center
San Antonio
Virginia
Nephrology Associates of Northern Virginia, Inc.
Fairfax
Vermont
University of Vermont Medical Center
Burlington
Wisconsin
Medical College of Wisconsin
Milwaukee
Milwaukee Nephrologists, SC
Wauwatosa
Other Locations
Australia
Royal Brisbane and Women's Hospital
Herston
John Hunter Hospital
New Lambton
The Royal Melbourne Hospital
Parkville
Melbourne Renal Research Group
Reservoir
France
Chu Grenoble Alpes
Grenoble
Hopital Necker, Universite Paris Descartes
Paris
Japan
Juntendo University Hospital
Bunkyō-ku
Jutendo University Hospital
Bunkyō-ku
Tokyo Metropolitan Children's Medical Center
Fuchū
St Marianna University Hospital
Kawasaki
Toranomon Hospital Kajigaya
Kawasaki
Kobe University Hospital
Kobe
Toranomon Hospital
Minato-ku
Japanese Red Cross Nagoya Daini Hospital
Nagoya
Niigata University Medical and Dental Hospital
Niigata
Kitano Hospital
Osaka
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka
Saga University Hospital
Saga
Saitama Children's Medical Center
Saitama-shi
Hokkaido University Hospital
Sapporo
JCHO Sendai Hospital
Sendai
Tokyo Women's Medical University Hospital
Shinjuku-ku
Osaka University Hospital
Suita
Puerto Rico
Puerto Rico Clinical and Translational Research Consortium (PRCTRC)
Rio Piedras
Spain
Fundacio Puigvert
Barcelona
Hospital Virgen de la Arrixaca
El Palmar
Time Frame
Start Date: 2019-03-08
Completion Date: 2023-08-23
Participants
Target number of participants: 270
Treatments
Experimental: Bardoxolone methyl
Adult participants received bardoxolone methyl capsules, once daily (QD) at a starting dose of 5 milligrams (mg), followed by dose- escalation to 10 mg at Week 2 (Day 14 ± 3), and to 20 mg at Week 4 (Day 28 ± 3). Based on the eligibility UACR \>300 milligrams per gram (mg/g), the dose was increased to 30 mg starting from Week 6 (Day 42 ± 3) until the end of the study.~Participants under 18 years of age received bardoxolone methyl capsules at a starting dose of 5 mg every other day during the first week and QD during the second week of the study, followed by dose-escalation to 10 mg at Week 2 and to 20 mg at Week 4. Based on the eligibility UACR \>300 mg/g, the dose was increased to 30 mg starting from Week 6 until the end of the study.
Sponsors
Leads: Biogen

This content was sourced from clinicaltrials.gov