Voclosporin for Lupus Nephritis
(VOCAL-EXT Trial)
Trial Summary
What is the purpose of this trial?
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 adolescents with active lupus nephritis.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, like cholestyramine, calcineurin inhibitors (such as cyclosporin and tacrolimus), and strong CYP3A4/5 inhibitors and inducers (like ketoconazole and rifampin), as they are not allowed during the study. However, you will need to continue taking oral MMF (mycophenolate mofetil) for the duration of the study.
What data supports the effectiveness of the drug Voclosporin for treating lupus nephritis?
Is voclosporin safe for humans?
How is the drug voclosporin unique for treating lupus nephritis?
Voclosporin is unique because it is an oral medication that works as a calcineurin inhibitor, which helps suppress the immune system to reduce kidney inflammation in lupus nephritis. It has shown improved kidney response rates compared to standard treatments, and it allows for the reduction of steroid use, which can have significant side effects.12347
Research Team
Aurinia Study Director
Principal Investigator
Aurinia Pharmaceuticals Inc.
Eligibility Criteria
This trial is for adolescents with active lupus nephritis who have completed a previous voclosporin study and need ongoing immunosuppressive therapy. They must be willing to take oral MMF throughout the study and not require dialysis or a kidney transplant during the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive open-label voclosporin in addition to background standard of care with MMF and oral steroids for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Continuation of voclosporin treatment for long-term safety and efficacy assessment
Treatment Details
Interventions
- Voclosporin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aurinia Pharmaceuticals Inc.
Lead Sponsor
Labcorp Corporation of America Holdings, Inc
Industry Sponsor