LUPKYNIS Drug-use Results Survey

NCT ID: NCT07053891

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-17

Study Completion Date

2032-06-30

Brief Summary

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The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.

Detailed Description

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Conditions

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Lupus Nephritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Voclosporin (LUPKYNIS)

In general, for adults, voclosporin should be administered orally at a dose of 23.7 mg BID. The dosage may be appropriately reduced depending on the patient's condition. In principle, at the start of treatment with voclosporin, it should be used in combination with corticosteroids and mycophenolate mofetil.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are newly starting administration of LUPKYNIS for lupus nephritis

Exclusion Criteria

\-
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pharmacovigilance Department

Osaka, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd

Role: CONTACT

+81-6-6943-7722

Facility Contacts

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Study Director

Role: primary

+81-6-6943-7722

Other Identifiers

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348-101-00044

Identifier Type: -

Identifier Source: org_study_id

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