Search / Trial NCT06611696

Avacopan Vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

Launched by CHIBA UNIVERSITY · Sep 22, 2024

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Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

Microscopic Polyangiitis Granulomatosis With Polyangiitis Avacopan Anca Associated Vasculitis

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 polyangiitis, granulomatosis with polyangiitis and eosinophilic granulomatosis with polyangiitis. ANCA-associated vasculitis can be a life-threatening disease and the mortality is 80% at 1 year in untreated patients. In 2010s, standard therapies for remission induction of ANCA-associated vasculitis were the combination of high-dose glucocorticoids and either cyclophosphamide or rituximab. Although thos...

Gender

ALL

Eligibility criteria

  • 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

About Chiba University

Chiba University, a leading research institution located in Chiba, Japan, is dedicated to advancing medical science and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses the expertise of its diverse faculty and state-of-the-art facilities to conduct rigorous research in various fields, including oncology, neurology, and regenerative medicine. Committed to ethical standards and patient safety, Chiba University strives to contribute to global health advancements by translating scientific discoveries into effective therapeutic interventions.

Locations

Toyoake, Aichi, Japan

Osaka, , Japan

Chiba, , Japan

Okayama, , Japan

Asahi, Chiba, Japan

Ichihara, Chiba, Japan

Kamogawa, Chiba, Japan

Narita, Chiba, Japan

Narita, Chiba, Japan

Maebashi, Gunma, Japan

Miki, Kagawa, Japan

Kawasaki, Kanagawa, Japan

Sendai, Miyagi, Japan

Kawagoe, Saitama, Japan

Mibu, Tochigi, Japan

Bunkyoku, Tokyo, Japan

Itabashiku, Tokyo, Japan

Mitaka, Tokyo, Japan

Ootaku, Tokyo, Japan

Chuou, Yamanashi, Japan

Chiba, , Japan

Nagasaki, , Japan

Itabashi, Tokyo, Japan

Otaku, Tokyo, Japan

Chuo Shi, Yamanashi, Japan

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0