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

Lupus Nephritis Clinical Trial

— ENLIGHT-LN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337124
• Other study ID #: AUR-VCS-2021-03
• Status: Recruiting
• Start date: March 25, 2022
• Est. completion date: June 1, 2030

Study information

• Verified date: May 2024
• Source: Aurinia Pharmaceuticals Inc.
• Contact: Aurinia Study Director
• Phone: 1-480-720-0394
• Email: clinicaltrials[@]auriniapharma.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2030
• Est. primary completion date: November 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• LUPKYNIS
LUPKYNIS treatment per the approved US Prescribing Information

Locations

Country	Name	City	State
United States	Site 00-05	S. Gate	California

Sponsors (2)

Lead Sponsor	Collaborator
Aurinia Pharmaceuticals Inc.	United BioSource, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LUPKYNIS utilization patterns	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)
Primary	Effectiveness of LUPKYNIS	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)