Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis (NCT05962788) | Clinical Trial Compass
TerminatedPhase 3
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
Stopped: DSMB recommendation
United States, Colombia, Japan4 participantsStarted 2024-03-28
Plain-language summary
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.
Who can participate
Age range5 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Incidence of Treatment Emergent Adverse Events (TEAE)
Timeframe: Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period