Voclosporin in Adolescents With Lupus Nephritis
The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active lupus nephritis (LN).
Conditions:
🦠 Adolescent Lupus Nephritis
🗓️ Study Start (Actual) 10 October 2023
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) January 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Chapel Hill, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
    • * Subjects with kidney biopsy confirmed active lupus nephritis.

    Exclusion Criteria:

    • * Estimated glomerular filtration rate (eGFR) \<60 mL/minute/1.73 m2 at screening.
    • * Current or medical history of:
    • * Congenital or acquired immunodeficiency.
    • * Clinically significant drug or alcohol abuse prior to screening.
    • * Malignant neoplasm.
    • * Lymphoproliferative disease or previous total lymphoid irradiation.
    • * Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
    • * Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
    • * Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
    • * Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
    • * Currently taking or known need for any of the following medications:
    • * Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.
Ages Eligible for Study: 12 Years to 17 Years (CHILD)
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 11 March 2022
  • First Submitted that Met QC Criteria 18 March 2022
  • First Posted 21 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 October 2023
  • Last Update Posted 23 October 2023
  • Last Verified October 2023