A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

NCT ID: NCT05337124

Last Updated: 2025-06-24

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

COMPLETED

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-05

Study Completion Date

2025-01-31

Brief Summary

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This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).

Detailed Description

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This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in patients with lupus nephritis (LN) in the United States (US). This registry is intended to benefit and support interests of patients, clinicians, regulatory bodies, payers, and industry by obtaining longitudinal data on LUPKYNIS.

Conditions

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Lupus Nephritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lupkynis Treatment Group

LUPKYNIS

Intervention Type DRUG

LUPKYNIS treatment per the approved US Prescribing Information

Interventions

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LUPKYNIS

LUPKYNIS treatment per the approved US Prescribing Information

Intervention Type DRUG

Other Intervention Names

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voclosporin

Eligibility Criteria

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Inclusion Criteria

* Lupus nephritis (LN) confirmed by biopsy
* Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI)
* Written informed consent

Exclusion Criteria

\- Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United BioSource, LLC

INDUSTRY

Sponsor Role collaborator

Aurinia Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aurinia Study Director

Role: STUDY_DIRECTOR

Aurinia Pharmaceuticals Inc.

Locations

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Site 00-05

South Gate, California, United States

Site Status

Countries

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United States

Other Identifiers

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AUR-VCS-2021-03

Identifier Type: -

Identifier Source: org_study_id

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