RecruitingPhase 4NCT06072482

A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis

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

Sponsor

Amgen

Enrollment

300 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

Antineutrophil Cytoplasmic Antibody-associated Vasculitis

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).

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Avacopan, a drug called Placebo, and others for people with antineutrophil cytoplasmic antibody-associated vasculitis. The study is currently recruiting participants at 80 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAvacopan

Administered orally.

DRUGPlacebo

Administered orally.

DRUGStandard 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(83)

Orthopedic Physicians Alaska

Anchorage, Alaska, United States

Scottsdale Healthcare at Shea - HonorHealth

Scottsdale, Arizona, United States

Southwest Kidney Institute

Surprise, Arizona, United States

Unity Health

Searcy, Arkansas, 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

Southland Arthritis and Osteoarthritis Medical Center, Inc

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

Amicis Research Center

Valencia, 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

Clinical Research Institute of Michigan

Saint Clair Shores, 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

Renal Medicine Associates

Albuquerque, New Mexico, 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

Carolina Kidney Associates

Greensboro, North Carolina, 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

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Allegheny Health Network Cancer Institute at Mellon Pavilion

Pittsburgh, Pennsylvania, United States

Nephrology Associates Inc

East Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Carolina Nephrology PA

Spartanburg, South Carolina, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Vital Rheumatology

Austin, Texas, United States

Renal Disease Research Institute - Landry Office

Dallas, Texas, United States

Epic Medical Research - Red Oak

Red Oak, 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 Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni nemocnice Ostrava

Ostrava - Poruba, Czechia

Fakultni nemocnice Plzen

Pilsen, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Revmatologicky ustav

Prague, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Aalborg Universitetshospital

Aalborg, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense Universitetshospital

Odense C, Denmark

General Hospital of Athens Laiko

Athens, Greece

Hippokration General Hospital of Athens

Athens, Greece

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

View Full Details on ClinicalTrials.gov

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NCT06072482

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