Status and phase
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About
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 adolescent and pediatric subjects with active lupus nephritis (LN).
Full description
This is a 24 week, dose escalation study of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids, consisting of 3 treatment periods: Period 1 is double-blind, placebo controlled receiving 15.8 mg twice daily, Period 2 is open-label receiving 23.7 mg twice daily, Period 3 is open-label receiving 15.8 mg twice daily.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Exclusion Criteria:
Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening.
Current or medical history of:
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:
Primary purpose
Allocation
Interventional model
Masking
40 participants in 4 patient groups, including a placebo group
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Aurinia Clinical Trials Information
Data sourced from clinicaltrials.gov
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