LUPKYNIS Drug-use Results Survey

NCT07053891 | Recruiting FDA Drug

• 1 other identifier: 348-101-00044
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (5)

• Safety Information (Number of Adverse Event)

  Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (ICH-E2A Guideline). An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product (LUPKYNIS), whether or not it is considered causally related to the Medicinal Product.

  3 years from the initiation of LUPKYNIS treatment

• Safety Information (Types of Special Situations and the Number of Corresponding Cases)

  Situations related to the use of an Otsuka product which may or may not be associated with an adverse event: * Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure; * Exposure during breastfeeding; * Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products); -Medication errors (e.g. patient took wrong dose); * Lack of therapeutic efficacy (e.g. the product doesn't work); * Occupational exposure (e.g.: nurse administering the product is exposed); * Cases of suspected transmission of infectious agents; * Use of suspected or confirmed falsified product(s) or quality defect of the product(s); * Withdrawal reactions; -Accidental exposure (e.g.: child takes parent's product); * Drug-drug/drug-food interactions; * Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population); * Disease progression/exacerbation of existing disease.

  3 years from the initiation of LUPKYNIS treatment

• Safety Information (Number of off-Label Use)

  Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.

  3 years from the initiation of LUPKYNIS treatment

• Safety Information (Number of Serious Adverse Event)

  Any adverse drug experience/event occurring at any dose which * results in death * is life-threatening * requires inpatient hospitalization or prolonged of existing hospitalization * results in persistent or significant disability or incapacity * is a congenital anomaly/birth defect * is medically significant.

  3 years from the initiation of LUPKYNIS treatment

• Safety Information (Number of Non-serious Adverse Events)

  All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events.

  3 years from the initiation of LUPKYNIS treatment

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in Japan who are planned to be newly started on LUPKYNIS for lupus nephritis.

You may qualify if:

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Pharmacovigilance Department

Osaka, Osaka, 540-0021, Japan

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Interventions

voclosporin

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd

CONTACT

+81-6-6943-7722; komaniwa.satoshi@otsuka.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

JP (1)