Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Launched by AURINIA PHARMACEUTICALS INC. · Mar 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called voclosporin to see how effective and safe it is for treating adolescents with lupus nephritis, a serious kidney condition caused by lupus. The trial will compare voclosporin to a placebo (a harmless pill with no active medicine) over 24 weeks to find out which helps improve kidney function better. The study is currently looking for participants aged between 13 and 17 who have been diagnosed with systemic lupus erythematosus and have had a kidney biopsy confirming active lupus nephritis.

To be eligible for this trial, participants must meet certain criteria, such as having a confirmed diagnosis of lupus and active kidney involvement. However, individuals with severe kidney issues, active infections, or those currently receiving certain medications may not qualify. Those who join the study can expect regular check-ups and assessments to monitor their health and the effectiveness of the treatment. It's an important opportunity to contribute to research that could improve treatment options for young people with this condition.

Gender

ALL

Eligibility 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.