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RECRUITING
NCT06611696
PHASE4

Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

Sponsor: Chiba University

View on ClinicalTrials.gov

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 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.

Official title: Avacopan With Short-term Reduced-dose Glucocorticoids vs Reduced-dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-associated Vasculitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-11-15

Completion Date

2028-09-30

Last Updated

2025-05-04

Healthy Volunteers

No

Interventions

DRUG

Avacopan, prednisolone and rituximab

Patients in the avacoapn group will be treated with avacoapn, short-term reduced-dose prednisolone and rituximab.

DRUG

Prednisolone and rituximab

Patients in the glucocorticoid arm will be treated with reduced-dose prednisolone and rituximab.

Locations (22)

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Asahi General Hospital

Asahi, Chiba, Japan

Chiba Aoba Municipal Hospital

Chiba, Chiba, Japan

Chiba University

Chiba, Chiba, Japan

Chiba Rosai Hospital

Ichihara, Chiba, Japan

Kameda Medical Centre

Kamogawa, Chiba, Japan

International University of Health and Welfare

Narita, Chiba, Japan

Japanese Red Cross Narita Hospital

Narita, Chiba, Japan

Gunma University

Maebashi, Gunma, Japan

Kagawa University

Hiragi, Kagawa-ken, Japan

St.Marianna University School of Medicine

Kawasaki, Kanagawa, Japan

Tohoku Univerisity

Sendai, Miyagi, Japan

Nagasaki University

Nagasaki, Nagasaki, Japan

Okayama University

Okayama, Okayama-ken, Japan

Kitano Hospital

Osaka, Osaka, Japan

Saitama Medical University

Kawagoe, Saitama, Japan

Dokkyo Medical University

Mibu, Tochigi, Japan

Juntendo Univeristy

Bunkyoku, Tokyo, Japan

Kyorin University

Mitaka, Tokyo, Japan

Toho University

Ōta-ku, Tokyo, Japan

Teikyo University

tabashi City, Tokyo, Japan

Yamanashi University

Chuo-shi, Yamanashi, Japan