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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
calcineurin inhibitor
matching placebo capsule
Nemours Children's Hospital, Orlando
Orlando, Florida, United States
Clinica de la Costa S.A.S
Barranquilla, Atlántico, Colombia
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Centro de Especialidades Medicas del Sureste
Mérida, Yucatán, Mexico
Proportion of subjects with renal response
Renal response defined as UPCR ≤0.5 mg/mg, eGFR ≥60 mL/min/1.73 m2 or no decrease from baseline of \>20%, no rescue medication and no steroid use \>10 mg/day for ≥3 consecutive days or for ≥7 days in total between week 16 to 24
Time frame: Week 24
Time to UPCR of ≤0.5 mg/mg.
Time in days to reduction in UPCR to ≤ 0.5 mg/mg
Time frame: Baseline to Week 24
Proportion of subjects with partial renal response
defined as ≥50% reduction from baseline in UPCR
Time frame: Week 24
Time to 50% Reduction in UPCR
Time in days to reduction from baseline UPCR of at least 50% Organ Class, and preferred term.
Time frame: Baseline to Week 24
Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group
Treatment-emergent adverse events will be summarized by treatment group, System Organ Class, and preferred term
Time frame: Baseline to Week 24
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Hospital Infantil de México Federico Gómez
Mexico City, Mexico
Siriraj Hospital
Bangkok, Thailand