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
Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Participants has provided informed consent before initiation of any study-specific activities/procedures.
• Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where induction treatment with cyclophosphamide or rituximab is needed.
• Age \>/= 18 years (or \>/= legal age within the country if it is older than 18 years).
• Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.
• At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, or at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
• eGFR \>/= 15 mL/min/1.73 m\^2 (using Chronic Kidney Disease Epidemiology Collaboration equations).
Locations
United States
Alaska
Orthopedic Physicians Alaska
TERMINATED
Anchorage
Arizona
Scottsdale Healthcare at Shea - HonorHealth
RECRUITING
Scottsdale
Southwest Kidney Institute
RECRUITING
Surprise
California
Medvin Clinical Research
RECRUITING
Covina
Palo Alto Medical Foundation Fremont
RECRUITING
Fremont
The Nephrology Group
RECRUITING
Fresno
Providence Medical Foundation
RECRUITING
Fullerton
Medvin Clinical Research
RECRUITING
Menifee
Harbor University of California at Los Angeles Medical Center
RECRUITING
Torrance
Colorado
University of Colorado
RECRUITING
Aurora
Florida
Florida Kidney Physicians
RECRUITING
Boca Raton
Malcom Randall Veterans Affairs Medical Center
RECRUITING
Gainesville
University of South Florida
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Dunes Clinical Research LLC
RECRUITING
Sioux City
Indiana
Lake Cumberland Rheumatology
RECRUITING
New Albany
Kentucky
University of Kentucky
RECRUITING
Lexington
Massachusetts
Brigham and Womens Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Michigan
Henry Ford Health System
RECRUITING
Detroit
Kidney Michigan Institute
RECRUITING
Saginaw
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
North Carolina
East Carolina University Brody Outpatient Center
RECRUITING
Greenville
Brookview Hills Research Associates Llc
RECRUITING
Winston-salem
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
Nevada
Renown Rheumatology
RECRUITING
Reno
New York
New York Nephrology Vasculitis and Glomerular Center
RECRUITING
Albany
Northwell Health
RECRUITING
Great Neck
Hospital For Special Surgery
RECRUITING
New York
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
The Ohio State University
RECRUITING
Columbus
Stat Research
RECRUITING
Miamisburg
Oklahoma
Hightower Clinical
RECRUITING
Oklahoma City
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Allegheny Health Network Cancer Institute at Mellon Pavilion
RECRUITING
Pittsburgh
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Rhode Island
Nephrology Associates Inc
RECRUITING
East Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Renal Disease Research Institute - Landry Office
RECRUITING
Dallas
Scott and White Memorial Hospital
RECRUITING
Temple
Virginia
Nephrology Associates of Northern Virginia Inc
RECRUITING
Fairfax
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
West Virginia
Rheumatology and Pulmonary Clinic
RECRUITING
Beckley
Other Locations
Hungary
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Pecsi Tudomanyegyetem Klinikai Kozpont
RECRUITING
Pécs
Poland
Spzoz Centralny Szpital Kliniczny Umed w Lodzi
RECRUITING
Lodz
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
RECRUITING
Lodz
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
RECRUITING
Warsaw
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy Centralny Szpital Kliniczny Mon
RECRUITING
Warsaw
Romania
Spitalul Clinic Dr Ion Cantacuzino
RECRUITING
Bucharest
Spitalul Clinic Sf Maria, Bucuresti
RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Cluj
RECRUITING
Cluj-napoca
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-02-07
Estimated Completion Date: 2036-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Group A: Avacopan + Standard of Care (SoC)
Avacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.
Experimental: Group B: Avacopan/Placebo + SoC
Avacopan 30 mg twice daily for 1 year, followed by placebo twice daily for 4 years + SoC background immunosuppressive therapy.
Placebo_comparator: Group C: Placebo + SoC
Placebo twice daily for 5 years + SoC background immunosuppressive therapy.
Related Therapeutic Areas
Sponsors
Leads: Amgen