About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Prior treatment for ANCA-associated vasculitis before trial entry
ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml/min) or alveolar hemorrhage (oxygen inhalation more than 2L/min)
Presence of another multisystem autoimmune disease
Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection
Trial design
Treatments tested in this trial
- Avacopan, prednisolone and rituximab
- Prednisolone and rituximab
Treatment groups
Sponsors and collaborators
Chiba University
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Collaborator
International University of Health and Welfare
Collaborator