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 adolescent and pediatric subjects with lupus nephritis.
This is a 12 month, prospective, multi-center, long-term, open-label extension study of voclosporin in addition to background standard of care with mycophenolate mofetil (MMF) and oral steroids. Subjects completing participation and treatment with study drug (voclosporin/placebo) of the VOCAL Study (AUR-VCS-2020-03 ; NCT05288855) and meeting all eligibility criteria will receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of VOCAL. All subjects will continue to receive background therapy of MMF and oral corticosteroids starting at the same dose as at completion of the VOCAL study. When clinically indicated, subjects are permitted to be titrated off oral corticosteroids.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Subjects will receive 2 capsules (15.8 mg) BID (twice daily), 3 capsules (23.7 mg) BID of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids.
UNC-Chapel Hill
Chapel Hill, North Carolina, 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
Incidence of Treatment Emergent Adverse Events (TEAE)
Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA
Time frame: Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period
Renal Response
Proportion of subjects with renal response at Month 12 and 18, defined based on the following parameters: * urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg, and * estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20%, and * Received no rescue medication for lupus nephritis, and * Did not receive \>10 mg/day prednisone for ≥3 consecutive days or for ≥7 days in total prior to the renal response assessment
Time frame: Per protocol from Study Start to Study Completion plus a 30-day follow-up period
Urine Protein Creatinine Ratio (UPCR)
Proportion of subjects with UPCR of ≤0.7 mg/mg
Time frame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
Partial Renal Response
Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR
Time frame: Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion)
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Hospital Infantil de México Federico Gómez
Mexico City, Mexico
Siriraj Hospital
Bangkok, Thailand