Last updated on September 2017

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

The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the prevention of recurrent Focal Segmental Glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with protein-creatinine ratio (≥ 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS.

Detailed Study Description

The study will consist of the following periods: Screening (Days -21 to -1), Transplant (Day 0), Post-Transplant (Day 0/post-skin closure through 12 months post-transplant). All subjects will enter into a Screening Period (Days -21 to -1 prior to transplant), undergo a Transplant (Day 0 [zero]), and are then to be followed for up to 12 months in the Post-Transplant Period (Day 0 through 12 months post-transplant).

Clinical Study Identifier: NCT02921789

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Stanford School of Medicine
Palo Alto, CA United States
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New Orleans, LA United States
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Saint Louis, MO United States
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Livingston, NJ United States
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Buffalo, NY United States
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Montefiore Medical Center
The Bronx, NY United States
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Integris/Nazih Zudhi Transplant Institute
Oklahoma City, OK United States
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Pinnacle Health
Harrisburg, PA United States
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Medical University of South Carolina
Charleston, SC United States
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Dallas, TX United States
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Fort Worth, TX United States
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Houston, TX United States
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Salt Lake City, UT United States
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Charlottesville, VA United States
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Swedish Medical Center
Seattle, WA United States
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