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A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis
Status: Recruiting
The aim of this study is to investigate whether voclosporin, added to standard treatment, is able to reduce activity of lupus nephritis over a study treatment period of 24 weeks, and to determine its safety as well as the best dose for treatment of lupus nephritis in children or adolescents.
Sex: Male or Female
Age Group: Up to 18 years old
Inclusion Criteria:
• 12 to 17 years old
• diagnosis of systemic lupus erythematosus (SLE)
• active lupus nephritis confirmed by a kidney biopsy
Exclusion Criteria:
• currently need dialysis
• clinically significant active medical or mental health conditions (study staff will review)
• certain medications, including: immunosuppression biologic agents, cyclophosphamide, calcineurin inhibitors (CNIs), start or change dose of ACE inhibitors/ARBs within 4 weeks prior to starting study, IV corticosteroids and IV immunoglobulin within 2 weeks of starting study
Interventions:
Drug: Placebo Oral Capsule, Drug: Voclosporin
Conditions:
Immune Diseases, Kidney, Prostate & Urinary
Keywords:
Adolescent Lupus Nephritis, Lupus, Nephritis
Study Contact: Anael Kuperwajs Cohen - kuper029@umn.edu
Principal Investigator: Michelle Rheault
Phase: PHASE3
IRB Number: SITE00001866
See this study on ClinicalTrials.gov