Last updated on August 2018

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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UCSF
San Francisco, CA United States
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Chicago, IL United States
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Tulane University Health Service Center
New Orleans, LA United States
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University of Maryland
Baltimore, MD United States
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Washington University in St. Louis
Saint Louis, MO United States
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St. Barnabas
Livingston, NJ United States
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Erie County Medical Center
Buffalo, 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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Baylor University Medical Center
Dallas, TX United States
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Baylor All Saints Medical Center
Fort Worth, TX United States
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The Methodist Hospital
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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California Pacific Medical Center
San Francisco, CA United States
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University of Colorado
Aurora, CO United States
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Northwestern University
Chicago, IL United States
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Indiana University
Indianapolis, IN United States
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University of Louisville
Louisville, KY United States
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Montefiore Medical Center
Bronx, NY United States
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University of North Carolina
Chapel Hill, NC United States
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Durham, NC United States
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Pittsburgh, PA United States
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Tampa General Hospital
Tampa, FL United States
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University of Pennsylvania Health System, PCAM
Philadelphia, PA United States
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University of Miami
Miami, FL United States
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Augusta University/Georgia Regents
Augusta, GA United States
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NYU Transplant Institute
New York, NY United States
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Columbia University Medical Center
New York, NY United States
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University of Alabama at Birmingham
Birmingham, AL United States
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University of Arizona
Tucson, AZ United States
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University of Illinois, Chicago
Chicago, IL United States
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