Status:
ENROLLING_BY_INVITATION
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
Lead Sponsor:
Aurinia Pharmaceuticals Inc.
Conditions:
Adolescent Lupus Nephritis
Pediatric Lupus Nephritis
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a 12 month, prospective, multi-center, long-term, open-label extension study of voclosporin in addition to background standard of care with mycophenolate mofetil (MMF) and oral steroids. Subj...
Eligibility Criteria
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)
- 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
Key Trial Info
Start Date :
March 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05962788
Start Date
March 27 2024
End Date
June 1 2029
Last Update
June 18 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27514
2
Clinica de la Costa S.A.S
Barranquilla, Atlántico, Colombia, 76100
3
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
4
Hospital Infantil de México Federico Gómez
Mexico City, Mexico City, Mexico, 06720