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A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
Sponsor: Amgen
Summary
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Official title: A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-02-07
Completion Date
2036-12-31
Last Updated
2026-01-29
Healthy Volunteers
No
Interventions
Avacopan
Administered orally.
Placebo
Administered orally.
Standard of Care
All participants will receive SoC background immunosuppressive therapy for induction and maintenance, at the discretion of the Investigator and as supported by current guidelines, product labels and local practices and informed by the individual participant's clinical condition, preferences, and values.
Locations (68)
Orthopedic Physicians Alaska
Anchorage, Alaska, United States
Scottsdale Healthcare at Shea - HonorHealth
Scottsdale, Arizona, United States
Southwest Kidney Institute
Surprise, Arizona, United States
Medvin Clinical Research
Covina, California, United States
Palo Alto Medical Foundation Fremont
Fremont, California, United States
The Nephrology Group
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
Medvin Clinical Research
Menifee, California, United States
University of California San Francisco- Zuckerburg San Francisco General
San Francisco, California, United States
Harbor University of California at Los Angeles Medical Center
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
Florida Kidney Physicians
Boca Raton, Florida, United States
Malcom Randall Veterans Affairs Medical Center
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
ClinTrial Research Oakwater, Llc
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Lake Cumberland Rheumatology
New Albany, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Dunes Clinical Research LLC
Sioux City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Kidney Michigan Institute
Saginaw, Michigan, United States
Revive Research Institute
Sterling Heights, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Renown Rheumatology
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Nephrology Vasculitis and Glomerular Center
Albany, New York, United States
Northwell Health
Great Neck, New York, United States
Hospital For Special Surgery
New York, New York, United States
East Carolina University Brody Outpatient Center
Greenville, North Carolina, United States
Brookview Hills Research Associates Llc
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Stat Research
Miamisburg, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Nephrology Associates Inc
East Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Renal Disease Research Institute - Landry Office
Dallas, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Fakultni nemocnice Olomouc
Olomouc, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Revmatologicky ustav
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland
Spzoz Centralny Szpital Kliniczny Umed w Lodzi
Lodz, Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy Centralny Szpital Kliniczny Mon
Warsaw, Poland
Spitalul Clinic Sf Maria, Bucuresti
Bucharest, Romania
Spitalul Clinic Dr Ion Cantacuzino
Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, Romania