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

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: LUPKYNIS

• Registration Number: NCT05337124
• Lead Sponsor: Aurinia Pharmaceuticals Inc.

Brief 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).

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 Timeline

• Study First Submitted: 2022-03-22
• Study Start: 2022-04-05
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lupkynis Treatment Group	LUPKYNIS	-

Primary Outcome Measures

Name	Time	Method
LUPKYNIS utilization patterns	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.
Effectiveness of LUPKYNIS	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.

Trial Locations

Locations (1)

Site 00-05; 🇺🇸 South Gate, California, United States