Testing avacopan with short-term steroids and rituximab for ANCA-associated vasculitis
Tests avacopan with short steroid courses in adults with newly diagnosed ANCA-associated vasculitis.
Plain-language title generated from the registry record
Registry title: Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis
Key facts
- Where
- Asahi, Bunkyoku, Chiba, Chuo-shi, Hiragi, Ichihara, Kamogawa, Kawagoe, Kawasaki, Maebashi, Mibu, Mitaka, Nagasaki, Narita, Okayama, Osaka, Ōta-ku, Sendai, tabashi City, and Toyoake, JapanSee the 22 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed ANCA-associated vasculitis. It compares avacopan with a short course of lower-dose steroids against lower-dose steroids for 20 weeks, both with rituximab.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- New diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis or microscopic polyangiitis)
- Earlier treatment
- No earlier treatment for ANCA-associated vasculitis. No B cell depleting drug (such as rituximab or belimumab) in the past 6 months. No earlier use of avacopan.
- Biomarker or test result
- Positive blood test for proteinase 3-ANCA or myeloperoxidase-ANCA
Main reasons for not taking part
- Kidney inflammation from the vasculitis with eGFR less than 15ml/min, or lung bleeding needing oxygen of more than 2L/min
- Another multisystem autoimmune disease
- HIV, or past or current hepatitis B or hepatitis C infection
- Pregnancy, breastfeeding, or wish to have children
- Cancer in the past 5 years, or active tuberculosis in the last year
Read by machine on 12 November 2026.
Where in Japan
- Asahi General HospitalAsahi, JapanContact: ShinIchiro Kagami, MD, PhDTaking people
- Juntendo UniveristyBunkyoku, JapanContact: Naoto Tamura, MD, PhDTaking people
- Chiba Aoba Municipal HospitalChiba, JapanContact: Yoshihisa Kobayashi, MD, PhDTaking people
- Chiba UniversityChiba, JapanContact: Shunsuke Furuta, MD, PhDTaking people
- Yamanashi UniversityChuo-shi, JapanContact: Daiki Nakagomi, MD, PhDTaking people
- Kagawa UniversityHiragi, JapanContact: Hiroaki Dobashi, MD, PhDTaking people
- Chiba Rosai HospitalIchihara, JapanContact: Tomohiro Tamachi, MD, PhDTaking people
- Kameda Medical CentreKamogawa, JapanContact: Tomo Suzuki, MDTaking people
- Saitama Medical UniversityKawagoe, JapanContact: Takahiko Kurasawa, MD, PhDTaking people
- St Marianna University School of MedicineKawasaki, JapanContact: Kimito Kawahata, MD, PhDTaking people
- Gunma UniversityMaebashi, JapanContact: Keijyu Hiromura, MD, PhDTaking people
- Dokkyo Medical UniversityMibu, JapanContact: Kei Ikeda, MD, PhDTaking people
- Kyorin UniversityMitaka, JapanContact: Yoshinori Komagata, MD, PhDTaking people
- Nagasaki UniversityNagasaki, JapanContact: Atsushi Kawakami, MD, PhDTaking people
- International University of Health and WelfareNarita, JapanContact: Masayoshi Harigai, MD, PhDTaking people
- Japanese Red Cross Narita HospitalNarita, JapanContact: Masaki Hiraguri, MDTaking people
- Okayama UniversityOkayama, JapanContact: Yoshinori Matsumoto, MD, PhDTaking people
- Kitano HospitalOsaka, JapanContact: Tomomi Endo, MDTaking people
- Toho UniversityŌta-ku, JapanContact: Toshihiro Nanki, MD, PhDTaking people
- Tohoku UniverisitySendai, JapanContact: Hiroshi Fujii, MD, PhDTaking people
- Teikyo Universitytabashi City, JapanContact: Hajime Kono, MD, PhDTaking people
- Fujita Health University HospitalToyoake, JapanContact: Naotake Tsuboi, MD, PhDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chiba University
- Trial code
- NCT06611696
- Record updated
- 4 May 2025
- Original description
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:Read full original descriptionShow less
Avacopan With Short-term Reduced-dose Glucocorticoids vs Reduced-dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-associated Vasculitis
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.
Inclusion: Provision of written informed consent by a patient or a surrogate decision maker; Age=\>18 years; New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis, microscopic polyangiitis) consistent with the 2012 Chapel Hill consensus definitions and 2022 EULAR/ACR classification criteria; Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA.
Exclusion: Prior treatment for ANCA-associated vasculitis before trial entry; Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg; Presence of another multisystem autoimmune disease; Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection; History of malignancy within the past 5 years or any evidence of persistent malignancy; Ongoing or recent (last 1 year) evidence of active tuberculosis; History of severe allergy or anaphylaxis to monoclonal antibody therapy; Past history of medication of avacopan; Other conditions, in the investigator\'s opinion, inappropriate for the trial entry; ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml/min) or alveolar hemorrhage (oxygen inhalation more than 2L/min); Desire to bear children, pregnancy or lactating; Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months; Patients can not take avacopan and prednisolone orally.