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โ† Trials
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Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

RecruitingPhase 4Ages 18 Years - anyAllChiba University
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In plain words

What the trial is, and whether it could suit you

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) a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Provision of written informed consent by a patient or a surrogate decision maker 2. Age=\>18 years 3. 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 4. Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA Exclusion Criteria: 1. Prior treatment for ANCA-associated vasculitis before trial entry 2. ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml/min) or alveolar hemorrhage (oxygen inhalation more than 2L/min) 3. Presence of another multisystem autoimmune disease 4. Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection 5. Desire to bear children, pregnancy or lactating 6. History of malignancy within the past 5 years or any evidence of persistent malignancy 7. Ongoing or recent (last 1 year) evidence of active tuberculosis 8. History of severe allergy or anaphylaxis to monoclonal antibody therapy 9. Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg 10. Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months 11. Past history of medication of avacopan 12. Patients can not take avacopan and prednisolone orally 13. Other conditions, in the investigator\'s opinion, inappropriate for the trial entry
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What it tests

  • Avacopan, prednisolone and rituximab
  • Prednisolone and rituximab
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Where

22 sites
Fujita Health University Hospital
Toyoake, Japan
Asahi General Hospital
Asahi, Japan
Chiba Aoba Municipal Hospital
Chiba, Japan
Chiba University
Chiba, Japan
Chiba Rosai Hospital
Ichihara, Japan
Kameda Medical Centre
Kamogawa, Japan
International University of Health and Welfare
Narita, Japan
Japanese Red Cross Narita Hospital
Narita, Japan

โ€ฆand 14 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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