Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With ANCA-Associated Vasculitis
Led by Amgen · Updated on 2026-05-29
300
Participants Needed
79
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of avacopan in people with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a condition involving inflammation of blood vessels. This phase 4 clinical trial focuses on assessing the safety and efficacy of avacopan over an extended period to understand its impact when combined with standard immunosuppressive treatments. Participants are randomly assigned to one of three groups: one group receives 30 mg of avacopan twice daily for 5 years along with standard care; another group takes avacopan for 1 year followed by placebo for 4 years, plus standard care; the third group receives placebo twice daily for 5 years combined with standard care. Standard care includes background immunosuppressive therapy tailored by the investigator according to guidelines and individual patient needs. Throughout the study, participants undergo regular monitoring for treatment-emergent adverse events, serious adverse events, and changes in vital signs, blood, urine, and serum chemistry over 60 months. Researchers also measure remission rates, relapse times, kidney function, quality of life, and glucocorticoid or immunosuppressant use. The study spans up to 5 years, with ongoing assessments to evaluate long-term safety and health outcomes.
CONDITIONS
Brief Title
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants have provided informed consent before any study activities.
- Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis requiring induction treatment with cyclophosphamide or rituximab.
- Age 18 years or older (or legal age if higher in the participant's country).
- Positive test for anti-proteinase 3 or anti-myeloperoxidase antibodies.
- At least 1 major or 3 nonmajor Birmingham Vasculitis Activity Score (BVAS) items, or the 2 renal items of proteinuria and hematuria.
- Estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73 m² or higher.
You will not qualify if you...
- Alveolar hemorrhage needing invasive ventilation expected beyond screening.
- Other multisystem autoimmune diseases like eosinophilic granulomatosis, lupus, IgA vasculitis, rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.
- Medical conditions requiring ongoing immunosuppressive therapies that may affect study results.
- Received dialysis or plasma exchange within 16 weeks before randomization.
- History of kidney transplant.
- Malignancy within 5 years except certain treated skin or cervical/breast cancers.
- Active hepatitis B or C, or HIV infection during screening.
- Known exposure to active tuberculosis within 12 weeks or positive TB test.
- Low white blood cell, neutrophil, or lymphocyte counts.
- Significant liver disease or abnormal liver enzyme levels.
- Serious infection or certain infections within 6 weeks before randomization.
- Recent cardiovascular events or unstable heart conditions within 12 weeks.
- Recent use of cyclophosphamide or rituximab within specified timeframes before consent.
- Use of strong or moderate CYP3A4 enzyme inducers unless changed before randomization.
- Use of investigational drugs within 30 days or 5 half-lives before randomization.
- Prior use of avacopan without benefit or within 60 days before randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants take Avacopan or placebo orally along with standard immunosuppressive therapy for ANCA-associated vasculitis.
Trial Site Locations
Total: 79 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
Carolina Kidney Associates
Greensboro, North Carolina, United States, 27405
Actively Recruiting
39
East Carolina University Brody Outpatient Center
Greenville, North Carolina, United States, 27834
Actively Recruiting
40
Brookview Hills Research Associates Llc
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
41
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
42
The Ohio State University
Columbus, Ohio, United States, 43201
Actively Recruiting
43
Stat Research
Miamisburg, Ohio, United States, 45342
Actively Recruiting
44
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73114
Actively Recruiting
45
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
46
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
47
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
48
Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
49
Nephrology Associates Inc
East Providence, Rhode Island, United States, 02914
Actively Recruiting
50
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
51
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Actively Recruiting
52
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
53
Vital Rheumatology
Austin, Texas, United States, 78727
Actively Recruiting
54
Renal Disease Research Institute - Landry Office
Dallas, Texas, United States, 75204
Actively Recruiting
55
Epic Medical Research - Red Oak
Red Oak, Texas, United States, 75154
Actively Recruiting
56
Scott and White Memorial Hospital
Temple, Texas, United States, 76502
Actively Recruiting
57
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia, United States, 22033
Actively Recruiting
58
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Terminated
59
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, United States, 25801
Actively Recruiting
60
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
61
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
62
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
Actively Recruiting
63
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czechia, 708 52
Actively Recruiting
64
Fakultni nemocnice Plzen
Pilsen, Czechia, 304 60
Actively Recruiting
65
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
66
Revmatologicky ustav
Prague, Czechia, 128 00
Actively Recruiting
67
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 128 08
Actively Recruiting
68
Aalborg Universitetshospital
Aalborg, Denmark, 9000
Actively Recruiting
69
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
70
Odense Universitetshospital
Odense C, Denmark, 5000
Actively Recruiting
71
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
72
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary, 7632
Actively Recruiting
73
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland, 90-153
Actively Recruiting
74
Spzoz Centralny Szpital Kliniczny Umed w Lodzi
Lodz, Poland, 92-213
Actively Recruiting
75
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, Poland, 02-637
Actively Recruiting
76
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy Centralny Szpital Kliniczny Mon
Warsaw, Poland, 04-141
Actively Recruiting
77
Spitalul Clinic Sf Maria, Bucuresti
Bucharest, Romania, 011172
Actively Recruiting
78
Spitalul Clinic Dr Ion Cantacuzino
Bucharest, Romania, 020475
Actively Recruiting
79
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, Romania, 400006
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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