NOT_YET_RECRUITING
Long-Term Voclosporin Treatment in Adolescent Subjects With Lupus Nephritis
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescents with active lupus nephritis.
Conditions:
🦠 Adolescent Lupus Nephritis
🗓️ Study Start (Actual) March 2024
🗓️ Primary Completion (Estimated) June 2026
✅ Study Completion (Estimated) September 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Orlando, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations.
    • * Age-appropriate assent or informed consent from subject before any study-specific procedures are performed.
    • * Subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the VOCAL study. Subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after Medical Monitor approval.
    • * In the opinion of the Investigator subject requires continued immunosuppressive therapy.
    • * Subject is willing to continue to take oral MMF for the duration of the study.

    Exclusion Criteria:

    • * Currently taking or known need for any of the following medications during the study:
    • * Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF
    • * Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus)
    • * Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin)
    • * Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
    • * A planned kidney transplant within study treatment period.
    • * Subjects with any medical condition which in the Investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes
Ages Eligible for Study: 12 Years to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 June 2023
  • First Submitted that Met QC Criteria 18 July 2023
  • First Posted 27 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 January 2024
  • Last Update Posted 30 January 2024
  • Last Verified January 2024