LUPKYNIS Drug-use Results Survey

Sponsor
Otsuka Pharmaceutical Co., Ltd.
Study ID
NCT07053891
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Voclosporin (LUPKYNIS) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 17, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2031
Completion
Jun 30, 2032

Study Design

Enrollment
400 participants (estimated)

Primary Outcome Measure

Safety Information (Number of Adverse Event) [ Time Frame: 3 years from the initiation of LUPKYNIS treatment ]

Central Contacts

  • Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
    +81-6-6943-7722
    [email protected]

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