A Prospective Observational Registry of Patients Treated... | NCT05337124

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

NCT05337124

Sponsor

Aurinia Pharmaceuticals Inc.

Status

Completed

Last Update Posted

Jun 24, 2025Actual

Enrollment

229Actual

Phase

Not provided

Conditions

Lupus Nephritis

Interventions

LUPKYNIS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2022Actual

Primary Completion Date

Jan 31, 2025Actual

Completion Date

Jan 31, 2025Actual

First Submitted Date

Mar 22, 2022

First Submission Date that Met QC Criteria

Apr 13, 2022

First Posted Date

Apr 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2025

Last Update Posted Date

Jun 24, 2025Actual

Name	Class
United BioSource, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

60 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

229Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lupkynis Treatment Group			Drug: LUPKYNIS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LUPKYNIS	Drug	LUPKYNIS treatment per the approved US Prescribing Information	Lupkynis Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All lupus nephritis patients that meet the eligibility criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aurinia Study Director	Aurinia Pharmaceuticals Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 00-05		South Gate	California	90280	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008181	Lupus Nephritis

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C484071	voclosporin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided