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OpenTrials
Completed

NCT Number: NCT05337124

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LUPKYNIS

Drug

LUPKYNIS treatment per the approved US Prescribing Information

Other names: voclosporin

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Aurinia Pharmaceuticals Inc.

Industry

Collaborators

  • United BioSource, LLC

Registry information

Acronym: ENLIGHT-LN

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2022
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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