Status:
RECRUITING
Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis
Lead Sponsor:
Chiba University
Collaborating Sponsors:
Kissei Pharmaceutical Co., Ltd.
International University of Health and Welfare
Conditions:
ANCA Associated Vasculitis (AAV)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 vasc...
Detailed Description
Anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitis is characterized by a small to medium-size vasculitis and the presence of ANCA. ANCA-associated vasculitis includes microscopic polyangi...
Eligibility Criteria
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
- 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
- Desire to bear children, pregnancy or lactating
- 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
- Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg
- Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months
- Past history of medication of avacopan
- Patients can not take avacopan and prednisolone orally
- Other conditions, in the investigator\'s opinion, inappropriate for the trial entry
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06611696
Start Date
November 15 2024
End Date
September 30 2028
Last Update
May 4 2025
Active Locations (22)
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1
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan, 4701192
2
Asahi General Hospital
Asahi, Chiba, Japan, 2892511
3
Chiba Aoba Municipal Hospital
Chiba, Chiba, Japan, 2600852
4
Chiba University
Chiba, Chiba, Japan, 2608677