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

June 18, 2025 updated by: Aurinia Pharmaceuticals Inc.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

229

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • South Gate, California, United States, 90280
        • Site 00-05

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All lupus nephritis patients that meet the eligibility criteria

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lupkynis Treatment Group
Drug: LUPKYNIS
LUPKYNIS treatment per the approved US Prescribing Information
Other Names:
  • voclosporin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LUPKYNIS utilization patterns
Time Frame: 12 months (1 year) to 60 months (5 years)
The proportion of patients that had their first Urine Protein Creatinine Ratio (UPCR) >0.5 mg within 6 months of initiating LUPKYNIS.
12 months (1 year) to 60 months (5 years)
Effectiveness of LUPKYNIS
Time Frame: 12 months (1 year) to 60 months (5 years)
The proportion of patients that achieve Urine Protein Creatinine Ratio (UPCR) <=0.5 mg after initiating LUPKYNIS by race, ethnicity, and previous LN treatment.
12 months (1 year) to 60 months (5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurinia Pharmaceuticals Inc.

Collaborators

United BioSource, LLC

Investigators

  • Study Director: Aurinia Study Director, Aurinia Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUR-VCS-2021-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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