Trial In Progress: Voclosporin in Adolescents with Lupus Nephritis (VOCAL) (NKF-SCM 2023) - Feb 18, 2023 - Abstract #309; Location: Exhibit Hall; P3 | "The Phase 3 AURORA 1 study showed that the addition of voclosporin to mycophenolate mofetil (MMF) and low-dose steroids in 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.2,3 Here we describe a Phase 3, dose-escalation study of voclosporin used in combination with MMF and low-dose steroids in a pediatric population with lupus nephritis. The primary efficacy endpoint is complete renal response (CRR; defined as urine protein creatinine ratio [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) at Week 24. Secondary endpoints include time to UPCR ≤0.5 mg/mg, partial renal response (≥50% reduction in UPCR from baseline), time to partial renal response, and safety...
Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease • Systemic Lupus Erythematosus
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Nicola Waddingham1; Amber Rosales1; Gigi Cheung1; Blake Potter1; Mary Palmen1; Christopher Collins1
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