Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
Megadott ok: DSMB recommendation
Key facts
- Where
- Mérida és Mexico City, MexikóSee the 2 sites
- Phase
- 3. fázis
Where in Mexikó
- Centro de Especialidades Medicas del SuresteMérida, MexikóNo longer taking part
- Hospital Infantil de Mexico Federico GomezMexico City, MexikóNo longer taking part
Trial details
- Who runs it
- Aurinia Pharmaceuticals Inc.
- Trial code
- NCT05962788
- Record updated
- 2026. február 10.
- Original description
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.Read full original descriptionShow less
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
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.
Inclusion: 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.
Exclusion: 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); 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; Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.