A Phase 2a Randomized Open-Label Active Control Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de novo Kidney Transplant Recipients

Brief description of study

This study is looking to enroll individuals may be getting kidney transplant from either a living or deceased donor. The individual must have a diagnosis of Focal Segmental Glomerulosclerosis (FSGS) to participate in this study. The purpose of this study is to determine if bleselumab (ASK1240, active study drug) is effective and safe in preventing recurrence of Focal Segmental Glomerulosclerosis (rFSGS) of a transplanted kidney when used in combination with tacrolimus, a medicine that is regularly used to prevent kidney transplant rejection. ASKP1240 is an investigational drug that is being tested and is not for sale by the US Food and Drug Administration (FDA). The study will consist of the following periods: -Screening (days -21 to -1) -Transplant (day 0 [zero]) -Post-transplant (day 0/post-skin closure through 12 months post-transplant)


Clinical Study Identifier: s16-01337
ClinicalTrials.gov Identifier: NCT02921789
Principal Investigator: Bruce E Gelb
Currently Recruiting

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