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RecruitingNCT06758271Updated Jan 17, 2025

Special Drug Use-results Survey for Long-term Use（Avacopan）

An observational study in Microscopic Polyangiitis (MPA) and Granulomatosis With Polyangiitis (GPA), sponsored by Kissei Pharmaceutical Co., Ltd.. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Sex
All
01

Study summary

The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

Read the detailed description

The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

02

Conditions studied

  • Microscopic Polyangiitis (MPA)
  • Granulomatosis With Polyangiitis (GPA)
03

In context

Microscopic Polyangiitis

69 studies on the registry are indexed under Microscopic Polyangiitis; 12 are open to participants now.

This study's planned enrollment of 250 is above the median of 200 across 26 observational studies indexed under Microscopic Polyangiitis.

Browse Microscopic Polyangiitis studies →

Lead sponsor

Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 63 studies on the registry; 3 are open to participants now.

Browse Kissei Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan

Eligibility criteria

Inclusion Criteria:

  • Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Avacopan treatmented

    Drug: Avacopan

Interventions

06

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Research site
    Multiple Locations, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2022 (actual). Primary completion is estimated for May 2028, 70 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2024
First posted
Jan 3, 2025
StartActual
Jul 29, 2022
Primary completionEst.
May 31, 2028
CompletionEst.
May 31, 2028
Last update
Jan 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06758271
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 3, 2025
Start date
Jul 29, 2022
Primary completion
May 31, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Jan 17, 2025

Study contacts

Kazunori Abe, director
Contact
rinsyousiken@pharm.kissei.co.jp
0356843575

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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