Actively Recruiting
Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis
Led by Chiba University · Updated on 2025-05-04
160
Participants Needed
22
Research Sites
202 weeks
Total Duration
On this page
Sponsors
C
Chiba University
Lead Sponsor
K
Kissei Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if avacopan in combination with short-term (4 weeks) reduced-dose glucocorticoid and rituximab works to treat patients with newly-onset ANCA-associated vasculitis. It will also learn about the long-term safety of avacopan. The main questions it aims to answer are: Is avacopan in combination with short-term reduced-dose glucocorticoid and rituximab as effective as the combination of 20 week reduced-dose glucocorticoid and rituximab in the proportion of the patients achieving remission? Does avacopan lower the relapse rate compared to the 6 monthly rituximab maintenance therapy? What medical problems do participants have when taking long-term avacopan? Participants will: Be treated with avacopan in combination with short-term (until 4 weeks) reduced-dose glucocorticoid and rituximab (at 0 week) or reduced-dose glucocorticoid (until 20 weeks) and rituximab (at 0, 26, 52 and 78 weeks). Be assessed at 0, 4, 8, 16, 26, 52, 78 and 104 weeks regarding disease status (remission/relapse), disease activity by Birmingham Vasculitis Activity Score ver3, disease damage by Vasculitis Damage Index and adverse events. The primary endpoint is remission rates at 26 weeks.
CONDITIONS
Official Title
Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be 18 years old or older
- Have a new diagnosis of ANCA-associated vasculitis including granulomatosis with polyangiitis or microscopic polyangiitis
- Test positive for proteinase 3-ANCA or myeloperoxidase-ANCA by specific antibody tests
You will not qualify if you...
- Have received any treatment for ANCA-associated vasculitis before this trial
- Have severe kidney disease related to ANCA vasculitis with eGFR less than 15 ml/min or require oxygen over 2L/min for alveolar hemorrhage
- Have another multisystem autoimmune disease
- Have current or past infections with HIV, hepatitis B, or hepatitis C
- Are pregnant, breastfeeding, or planning pregnancy
- Have had cancer within the past 5 years or active cancer
- Have active tuberculosis now or in the past year
- Have a history of severe allergy or anaphylaxis to monoclonal antibodies
- Need other systemic glucocorticoids, immunosuppressants, biologics, plasma exchange, or IVIg
- Have used B cell depleting biologics like rituximab or belimumab in the past 6 months
- Have taken avacopan before
- Cannot take avacopan or prednisolone by mouth
- Have any condition judged by the investigator to make trial participation inappropriate
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan, 4701192
Not Yet Recruiting
2
Asahi General Hospital
Asahi, Chiba, Japan, 2892511
Actively Recruiting
3
Chiba Aoba Municipal Hospital
Chiba, Chiba, Japan, 2600852
Actively Recruiting
4
Chiba University
Chiba, Chiba, Japan, 2608677
Actively Recruiting
5
Chiba Rosai Hospital
Ichihara, Chiba, Japan, 2900003
Actively Recruiting
6
Kameda Medical Centre
Kamogawa, Chiba, Japan, 2968602
Actively Recruiting
7
International University of Health and Welfare
Narita, Chiba, Japan, 2868520
Actively Recruiting
8
Japanese Red Cross Narita Hospital
Narita, Chiba, Japan, 2868523
Actively Recruiting
9
Gunma University
Maebashi, Gunma, Japan, 3718511
Actively Recruiting
10
Kagawa University
Hiragi, Kagawa-ken, Japan, 7610793
Actively Recruiting
11
St.Marianna University School of Medicine
Kawasaki, Kanagawa, Japan, 2168511
Actively Recruiting
12
Tohoku Univerisity
Sendai, Miyagi, Japan, 9808574
Actively Recruiting
13
Nagasaki University
Nagasaki, Nagasaki, Japan, 8528501
Actively Recruiting
14
Okayama University
Okayama, Okayama-ken, Japan, 7008558
Actively Recruiting
15
Kitano Hospital
Osaka, Osaka, Japan, 5308480
Actively Recruiting
16
Saitama Medical University
Kawagoe, Saitama, Japan, 3508550
Actively Recruiting
17
Dokkyo Medical University
Mibu, Tochigi, Japan, 3210293
Actively Recruiting
18
Juntendo Univeristy
Bunkyoku, Tokyo, Japan, 1138431
Actively Recruiting
19
Kyorin University
Mitaka, Tokyo, Japan, 1818611
Actively Recruiting
20
Toho University
Ōta-ku, Tokyo, Japan, 1438541
Actively Recruiting
21
Teikyo University
tabashi City, Tokyo, Japan, 1738606
Actively Recruiting
22
Yamanashi University
Chuo-shi, Yamanashi, Japan, 4093898
Actively Recruiting
Research Team
S
Shunsuke Furuta, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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