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Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

ConditionANCA Associated Vasculitis (AAV)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChiba University

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Avacopan, prednisolone and rituximab

    Drug

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

  • Prednisolone and rituximab

    Drug

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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Glucocorticoid groupActive comparator 1 intervention
Group B: Avacopan groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportions of patients achieving remission

Remission is defined as BVAS (Birmingham vasculitis activity score)=0 and less than 5mg/day of prednisolone.

Time frame
26 weeks

Secondary outcomes

1

Sustained remission without taking prednisolone at 104 weeks

Remission is defined as BVAS (Birmingham vasculitis activity score)=0 and less than 5mg/day of prednisolone.

Time frame
104 weeks
2

Survival, relapse and end-stage renal disease

Assessed by Kaplan-Meier curves.

Time frame
26 and 104 weeks
3

Accumulative dose of glucocorticoids

Accumulative dose of glucocorticoids during the study period

Time frame
26 and 104 weeks
4

Birmingham Vasculitis Activity Score (BVAS) version 3

BVAS is a scoring system for assessing the disease activity of vasculitis.

Time frame
26 and 104 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chiba University

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Collaborator

International University of Health and Welfare

Collaborator

Source ClinicalTrials.gov
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