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LUPKYNIS US Registry Trial

Sponsor
Aurinia Pharmaceuticals Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05337124
Collaborator
United BioSource, LLC (Industry)
300
Enrollment
1
Location
58.7
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Prospective Observational Registry of Patients Treated With LUPKYNIS™ (Voclosporin) in the US
Actual Study Start Date :
Mar 25, 2022
Anticipated Primary Completion Date :
Nov 15, 2026
Anticipated Study Completion Date :
Feb 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Lupkynis Treatment Group

Drug: LUPKYNIS
LUPKYNIS treatment per the approved US Prescribing Information
Other Names:
  • voclosporin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. LUPKYNIS utilization patterns [36 months]

      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 [36 months]

      The proportion of patients that achieve Urine Protein Creatinine Ratio (UPCR) <=0.5 mg after initiating LUPKYNIS by race, ethnicity, and previous LN treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 1005 S. Gate California United States 90280

    Sponsors and Collaborators

    • Aurinia Pharmaceuticals Inc.
    • United BioSource, LLC

    Investigators

    • Study Director: Amber Rosales, Aurinia Pharmaceuticals Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aurinia Pharmaceuticals Inc.
    ClinicalTrials.gov Identifier:
    NCT05337124
    Other Study ID Numbers:
    • AUR-VCS-2021-03
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nephritis
    Lupus Nephritis

    Study Results

    No Results Posted as of Jun 3, 2022