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Recruiting NCT07053891

LUPKYNIS Drug-use Results Survey

— Observational Lupus Nephritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Voclosporin (LUPKYNIS).
Who it may be relevant to
Registry conditions: Lupus Nephritis. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Safety Information (Number of Adverse Event) [Time frame: 3 years from the initiation of LUPKYNIS treatment]
  • Safety Information (Types of Special Situations and the Number of Corresponding Cases) [Time frame: 3 years from the initiation of LUPKYNIS treatment]
  • Safety Information (Number of off-Label Use) [Time frame: 3 years from the initiation of LUPKYNIS treatment]
  • Safety Information (Number of Serious Adverse Event) [Time frame: 3 years from the initiation of LUPKYNIS treatment]
  • Safety Information (Number of Non-serious Adverse Events) [Time frame: 3 years from the initiation of LUPKYNIS treatment]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 1 center
  • Pharmacovigilance Department — Osaka

Identifiers

NCT: NCT07053891 · 348-101-00044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗