Last updated 13 days ago
Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
40 patients around the world
Available in Colombia, United States, Mexico
This is a 24 week, dose escalation study of voclosporin in addition to standard of care
with mycophenolate mofetil (MMF) and steroids, consisting of 3 treatment periods: Period
1 is double-blind, placebo controlled receiving 15.8 mg twice daily, Period 2 is
open-label receiving 23.7 mg twice daily, Period 3 is open-label receiving 15.8 mg twice
daily.
Aurinia Pharmaceuticals Inc.
3Research sites
40Patients around the world
This study is for people with
Lupus
Lupus nephritis
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.Subjects with kidney biopsy confirmed active lupus nephritis.
- 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.
Sites
Clínica de la Costa - Barranquilla
Recruiting
Hospital Infantil de México Federico Gómez
Recruiting
CEM - Centro de Especialidades Médicas del Sureste
Recruiting
StudyVOCAL
SponsorAurinia Pharmaceuticals Inc.
Study typeInterventional
Conditions
Lupus nephritis
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05288855
