Voclosporin treatment for adolescents with lupus nephritis
A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents With Lupus Nephritis
This study is testing if a new medication called voclosporin can help teenagers with lupus nephritis feel better and improve their kidney function compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Aurinia Pharmaceuticals Inc. Industry-sponsored |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05288855 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of voclosporin, a calcineurin inhibitor, in adolescents diagnosed with active lupus nephritis. Over a 24-week period, participants will receive either voclosporin or a placebo in a double-blind manner, followed by open-label treatment with increasing doses of voclosporin alongside standard care, which includes mycophenolate mofetil and steroids. The goal is to determine the renal response to voclosporin compared to placebo in this pediatric population.
Who should consider this trial
Good fit: Ideal candidates are adolescents diagnosed with systemic lupus erythematosus and confirmed active lupus nephritis through kidney biopsy.
Not a fit: Patients with severe renal impairment or those requiring dialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney function and overall health outcomes for adolescents suffering from lupus nephritis.
How similar studies have performed: Previous studies have shown promise with calcineurin inhibitors in treating lupus nephritis, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria. * Subjects with kidney biopsy confirmed active lupus nephritis. Exclusion Criteria: * Estimated glomerular filtration rate (eGFR) \<60 mL/minute/1.73 m2 at screening. * Current or medical history of: * Congenital or acquired immunodeficiency. * Clinically significant drug or alcohol abuse prior to screening. * Malignant neoplasm. * Lymphoproliferative disease or previous total lymphoid irradiation. * Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening. * Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid. * Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. * Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes. * Currently taking or known need for any of the following medications: * Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.
Where this trial is running
Chapel Hill, North Carolina
- UNC-Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Antonia Coeshall
- Email: acoeshall@auriniapharma.com
- Phone: +44-7968-836321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.