Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis

Stopped early · Phase 3

Conditions studied: Adolescent Lupus Nephritis, Pediatric Lupus Nephritis

In brief

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.

Key facts

Study ID

NCT05962788

Run by

Aurinia Pharmaceuticals Inc.

People needed

4

Starts

2024-03-28

Expected to finish

2025-07-04

Last updated by the study team

2026-02-10

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations.
• Age-appropriate assent or informed consent from subject before any study-specific procedures are performed.
• Subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the VOCAL study. Subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after Medical Monitor approval.
• In the opinion of the Investigator subject requires continued immunosuppressive therapy.
• Subject is willing to continue to take oral MMF for the duration of the study.

You may not qualify if…

• Currently taking or known need for any of the following medications during the study:
• Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF
• Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus)
• Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin)
• Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• A planned kidney transplant within study treatment period.
• Subjects with any medical condition which in the Investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes

Where it is running

• 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
• Hospital Infantil de México Federico Gómez — Mexico City, Mexico
• Siriraj Hospital — Bangkok, Thailand

Full record on ClinicalTrials.gov

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