Actively Recruiting
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
Led by Amgen · Updated on 2026-05-14
300
Participants Needed
77
Research Sites
673 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide informed consent before starting any study procedures.
- Diagnosed with newly diagnosed or relapsed granulomatosis with polyangiitis or microscopic polyangiitis needing induction treatment with cyclophosphamide or rituximab.
- Aged 18 years or older (or legal adult age in the country if higher).
- Positive test for anti-proteinase 3 or anti-myeloperoxidase antibodies (current or historic).
- Presence of at least 1 major or 3 nonmajor Birmingham Vasculitis Activity Score (BVAS) items, or 2 renal items (proteinuria and hematuria).
- Estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73 m² or higher using Chronic Kidney Disease Epidemiology Collaboration equations.
You will not qualify if you...
- Alveolar hemorrhage requiring invasive pulmonary ventilation expected beyond screening.
- Other multisystem autoimmune diseases that could affect study assessments, including eosinophilic granulomatosis with polyangiitis, systemic lupus erythematosus, IgA vasculitis, rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.
- Medical conditions requiring ongoing immunosuppressive therapies that may interfere with study assessments.
- Received dialysis or plasma exchange within 16 weeks before randomization.
- History of kidney transplant.
- Malignancy within the last 5 years except certain treated skin or cervical/breast cancers.
- Active hepatitis B or C, or HIV infection during screening.
- Recent exposure to active tuberculosis or positive test for active or latent tuberculosis.
- Low white blood cell, neutrophil, or lymphocyte counts as specified.
- Significant liver disease or abnormal liver function tests beyond specified limits.
- Recent serious infections or infections requiring IV treatment within 6 weeks prior to randomization.
- Recent major cardiovascular events or unstable heart conditions within 12 weeks prior to randomization.
- Recent use of cyclophosphamide, rituximab, or other specified immunosuppressive drugs within defined timeframes.
- Use of strong or moderate CYP3A4 enzyme inducers unless changed to alternatives before randomization.
- Participation in another investigational drug trial within 30 days or 5 half-lives before randomization.
- Previous use of avacopan without clinical benefit or within 60 days before randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 77 locations
1
Orthopedic Physicians Alaska
Anchorage, Alaska, United States, 99508
Terminated
2
Scottsdale Healthcare at Shea - HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Southwest Kidney Institute
Surprise, Arizona, United States, 85374
Actively Recruiting
4
Unity Health
Searcy, Arkansas, United States, 72143
Actively Recruiting
5
Medvin Clinical Research
Covina, California, United States, 91722
Terminated
6
Palo Alto Medical Foundation Fremont
Fremont, California, United States, 94538
Actively Recruiting
7
The Nephrology Group
Fresno, California, United States, 93720
Actively Recruiting
8
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
9
Medvin Clinical Research
Menifee, California, United States, 92586
Actively Recruiting
10
University of California San Francisco- Zuckerburg San Francisco General
San Francisco, California, United States, 94110
Actively Recruiting
11
Harbor University of California at Los Angeles Medical Center
Torrance, California, United States, 90502
Actively Recruiting
12
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
13
Florida Kidney Physicians
Boca Raton, Florida, United States, 33431
Actively Recruiting
14
Malcom Randall Veterans Affairs Medical Center
Gainesville, Florida, United States, 32608
Actively Recruiting
15
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
16
ClinTrial Research Oakwater, Llc
Orlando, Florida, United States, 32806
Actively Recruiting
17
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
18
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
19
Lake Cumberland Rheumatology
New Albany, Indiana, United States, 47150
Actively Recruiting
20
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
21
Dunes Clinical Research LLC
Sioux City, Iowa, United States, 51104
Actively Recruiting
22
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
23
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
24
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
26
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
27
Kidney Michigan Institute
Saginaw, Michigan, United States, 49804
Actively Recruiting
28
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, United States, 48081
Actively Recruiting
29
Revive Research Institute
Sterling Heights, Michigan, United States, 48313
Actively Recruiting
30
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
31
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
32
Renown Rheumatology
Reno, Nevada, United States, 89502
Actively Recruiting
33
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
34
Renal Medicine Associates
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
35
New York Nephrology Vasculitis and Glomerular Center
Albany, New York, United States, 12209
Actively Recruiting
36
Northwell Health
Great Neck, New York, United States, 11021
Actively Recruiting
37
Hospital For Special Surgery
New York, New York, United States, 10021
Actively Recruiting
38
East Carolina University Brody Outpatient Center
Greenville, North Carolina, United States, 27834
Actively Recruiting
39
Brookview Hills Research Associates Llc
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
40
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
41
The Ohio State University
Columbus, Ohio, United States, 43201
Actively Recruiting
42
Stat Research
Miamisburg, Ohio, United States, 45342
Actively Recruiting
43
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73114
Actively Recruiting
44
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
45
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
46
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
47
Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
48
Nephrology Associates Inc
East Providence, Rhode Island, United States, 02914
Actively Recruiting
49
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
50
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Actively Recruiting
51
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
52
Vital Rheumatology
Austin, Texas, United States, 78727
Actively Recruiting
53
Renal Disease Research Institute - Landry Office
Dallas, Texas, United States, 75204
Actively Recruiting
54
Scott and White Memorial Hospital
Temple, Texas, United States, 76502
Actively Recruiting
55
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia, United States, 22033
Actively Recruiting
56
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Terminated
57
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, United States, 25801
Actively Recruiting
58
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
59
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
60
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
Actively Recruiting
61
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czechia, 708 52
Actively Recruiting
62
Fakultni nemocnice Plzen
Pilsen, Czechia, 304 60
Actively Recruiting
63
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
64
Revmatologicky ustav
Prague, Czechia, 128 00
Actively Recruiting
65
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 128 08
Actively Recruiting
66
Aalborg Universitetshospital
Aalborg, Denmark, 9000
Actively Recruiting
67
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
68
Odense Universitetshospital
Odense C, Denmark, 5000
Actively Recruiting
69
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
70
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary, 7632
Actively Recruiting
71
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland, 90-153
Actively Recruiting
72
Spzoz Centralny Szpital Kliniczny Umed w Lodzi
Lodz, Poland, 92-213
Actively Recruiting
73
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, Poland, 02-637
Actively Recruiting
74
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy Centralny Szpital Kliniczny Mon
Warsaw, Poland, 04-141
Actively Recruiting
75
Spitalul Clinic Sf Maria, Bucuresti
Bucharest, Romania, 011172
Actively Recruiting
76
Spitalul Clinic Dr Ion Cantacuzino
Bucharest, Romania, 020475
Actively Recruiting
77
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, Romania, 400006
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here