Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Conditions
Keywords
voclosporin, lupus nephritis, calcineurin inhibitors, adolescents, pediatrics
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 adolescent and pediatric subjects with lupus nephritis.
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. Subjects completing participation and treatment with study drug (voclosporin/placebo) of the VOCAL Study (AUR-VCS-2020-03 ; NCT05288855) and meeting all eligibility criteria will receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of VOCAL. All subjects will continue to receive background therapy of MMF and oral corticosteroids starting at the same dose as at completion of the VOCAL study. When clinically indicated, subjects are permitted to be titrated off oral corticosteroids.
Interventions
DRUGvoclosporin
Subjects will receive 2 capsules (15.8 mg) BID (twice daily), 3 capsules (23.7 mg) BID of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids.
Sponsors
Aurinia Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAE) | Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period | Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Response | Per protocol from Study Start to Study Completion plus a 30-day follow-up period | Proportion of subjects with renal response at Month 12 and 18, defined based on the following parameters: * urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg, and * estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20%, and * Received no rescue medication for lupus nephritis, and * Did not receive \>10 mg/day prednisone for ≥3 consecutive days or for ≥7 days in total prior to the renal response assessment |
| Urine Protein Creatinine Ratio (UPCR) | Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion) | Proportion of subjects with UPCR of ≤0.7 mg/mg |
| Partial Renal Response | Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion) | Proportion of subjects in partial renal response as defined by ≥50% reduction from VOCAL baseline in UPCR |
Countries
Colombia, Japan, Mexico, Thailand, United States
Outcome results
None listed