Voclosporin Treatment in Adolescents with Lupus Nephritis (VOCAL™) (KIDNEY WEEK 2023) - Oct 15, 2023 - Abstract #INFO17-FR; Pres time: Nov 3, 2023; 10:00 AM - 12:00 PM; Location: Exhibit Hall, Pennsylvania Convention Center; P3 | "The Phase 3 AURORA 1 study showed that the addition of voclosporin to mycophenolate mofetil (MMF) and low-dose glucocorticoids in adult patients ≥18 years of age yielded significant reductions in proteinuria; efficacy was maintained for an additional 24 months in patients who continued treatment in the AURORA 2 study.Here we describe a Phase 3, dose-escalation study of voclosporin used in combination with MMF and low-dose steroids in an adolescent population with lupus nephritis.The Voclosporin in Adolescents with Lupus Nephritis (VOCAL) study (NCT05288855) is a global Phase 3, 24-week, dose-escalation study of voclosporin consisting of three treatment periods; period 1 is double-blind and placebo-controlled, and periods 2 and 3 are open-label, with increasing doses of voclosporin administered in each period (15.8 mg BID, 23.7 mg BID, and 31.6 mg BID) in addition to MMF and low-dose steroids. Levy DM, et al. Pediatr Clin North Am 2012; 59(2):345-64."
Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease • Systemic Lupus Erythematosus
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Nicola C. Waddingham1; Amber Rosales1; Gigi Cheung1; Steven B. Potter1; Mary Palmen1
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