Study summary

The purpose of this study was 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 were imputed as rFSGS.

Additional Study Details

Phase
Phase 2
Product
bleselumab
Product
Bleselumab
Basiliximab
Mycophenolate Mofetil (MMF)
Tacrolimus Capsules
Methylprednisone
Prednisone
Type
Interventional
Masking
None (Open Label)
Enrollment number
67
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English
Protocol
Available Language(s): English
Statistical Analysis Plan (SAP)
Available Language(s): English

Get more information

Would you like more information about clinical trial sites that are recruiting participants for Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de novo Kidney Transplant Recipients? Contact us by filling out your information to the right and we’ll respond to you.

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  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

    Locations

    Contact Us
    Contact Us
    Completed
    University of Pennsylvania Health System, PCAM
    Philadelphia, PA, United States, 19104
    Withdrawn
    Pinnacle Health
    Harrisburg, PA, United States, 17104
    Withdrawn
    University of Alabama at Birmingham
    Birmingham, AL, United States, 35294
    Completed
    Site CA15002
    Edmonton, Alberta, Canada, TG6 2B7
    Withdrawn
    Swedish‐Medical Center
    Seattle, WA, United States, 98104
    Completed
    Site CA15005
    Vancouver, BC, Canada, V6Z 1Y6
    Withdrawn
    Tampa General Hospital
    Tampa, FL, United States, 33606
    Completed
    Medical University of South Carolina
    Charleston, SC, United States, 29425
    Withdrawn
    Baylor All Saints Medical Center
    Ft. Worth, TX, United States, 76104
    Completed
    Erie County Medical Center
    Buffalo, NY, United States, 14215
    Completed
    Tulane University Health Service Center
    New Orleans, LA, United States, 70112
    Withdrawn
    Integris/Nazih Zudhi Transplant Institute
    Oklahoma City, OK, United States, 73112
    Withdrawn
    Baylor University Medical Center
    Dallas, TX, United States, 75246
    Withdrawn
    Montefiore Medical Center
    Bronx, NY, United States, 10467
    Completed
    University of Utah Medical Center
    Salt Lake City, UT, United States, 84132
    Completed
    Columbia University Medical Center
    New York, NY, United States, 10032
    Withdrawn
    Augusta University/Georgia Regents
    Augusta, GA, United States, 30912
    Withdrawn
    Site CA15003
    Vancouver, British Columbia, Canada, V6Z 1Y6
    Completed
    University of Louisville
    Louisville, KY, United States, 40202
    Completed
    University of Colorado
    Aurora, CO, United States, 80045
    Withdrawn
    University of Pittsburgh Medical Center
    Pittsburgh, PA, United States, 15213
    Completed
    UCSF
    San Francisco, CA, United States, 94143
    Completed
    University of North Carolina
    Chapel Hill, NC, United States, 27713
    Completed
    Indiana University
    Indianapolis, IN, United States, 46220
    Withdrawn
    University of Illinois, Chicago
    Chicago, IL, United States, 60612
    Withdrawn
    California Pacific Medical Center
    San Francisco, CA, United States, 94115
    Withdrawn
    Northwestern University
    Chicago, IL, United States, 60611
    Withdrawn
    Methodist Hospital, The
    Houston, TX, United States, 77030
    Withdrawn
    Mount Sinai, Icahn School of Medicine
    New York, NY, United States, 10029
    Completed
    Washington University in St. Louis
    St. Louis, Mo, United States, 63110
    Completed
    Michigan Medicine
    Ann Arbor, MI, United States, 48109
    Completed
    University of Chicago
    Chicago, IL, United States, 60637
    Completed
    University of Miami
    Miami, FL, United States, 33136
    Completed
    Site CA15006
    Montreal, Quebec, Canada, H1T 2M4
    Completed
    Stanford School of Medicine
    Palo Alto, CA, United States, 94304
    Completed
    University of Virginia
    Charlottesville, VA, United States, 22908
    Completed
    Duke University Medical Center
    Durham, NC, United States, 27710
    Completed
    University of Arizona
    Tucson, AZ, United States, 85724
    Withdrawn
    NYU Transplant Institute
    New York, NY, United States, 10016
    Withdrawn
    University of Maryland
    Baltimore, MD, United States, 21201
    Withdrawn
    NY Presybyterian Hosp – Cornell University
    New York, New York, United States, 10065
    Completed
    St. Barnabas
    Livingston, NJ, United States, 07039

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