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
  • 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.

    • A caregiver
    • A healthcare provider
    • A parent
    • 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

      Frequently Asked Questions

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      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

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      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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