An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
Study Name: AUR-VCS-2017-03
An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
Principal Investigator: Amy Mottl, MD, MPH
Sponsor: Aurinia Pharmaceuticals Inc.
Age Range: 18-75
Status: Enrolling
Purpose: To learn if the investigational drug Voclosporin will decrease the amount of protein in the urine (proteinuria) in patients with focal segmental glomerulosclerosis (FSGS) after 24 weeks of therapy.
Study Procedures: Voclosporin (Orelvo) is an oral medication taken twice a day. Qualifying patients will begin this medication at day 1 and continue for 6 months with study visits at weeks 2, 4, 8, 12, 18, 24 and 25. Blood and urine will be collected at each study visit along with physical exams and disease activity assessments.
Participation: Participation will last approximately 6 months.
For more information, please contact:
Brenda Meier, RN
Study Coordinator
919-445-2730
brenda_meier@med.unc.edu