NCT05337124

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

April 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

March 22, 2022

Last Update Submit

June 18, 2025

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (1)

Lupkynis Treatment Group

Drug: LUPKYNIS

Interventions

LUPKYNISDRUG

LUPKYNIS treatment per the approved US Prescribing Information

Also known as: voclosporin
Lupkynis Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All lupus nephritis patients that meet the eligibility criteria

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 00-05

South Gate, California, 90280, United States

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

voclosporin

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Aurinia Study Director

    Aurinia Pharmaceuticals Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 20, 2022

Study Start

April 5, 2022

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)