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A randomized controlled trial of preemptive rituximab to prevent recurrent focal segmental glomerulosclerosis post-kidney transplant (PRI-VENT FSGS): protocol and study design

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Last modified
  • 06/25/2025
Type of Material
Authors
    Michelle N. Rheault, University of MinnesotaSandra Amaral, Children's Hospital of PhiladelphiaMargaret Bock, Children's Hospital of ColoradoEileen Tsai Chambers, Duke UniversityBlanche Chavers, University of MinnesotaMireile El Ters, Mayo Clinic, Rochester MNRouba Garro, Emory UniversityRasheed Gbadegesin, Duke UniveristyAmit Govil, University of CincinnatiLyndsay Harshman, University of IowaHatem Amer, Mayo Clinic, Rochester, MNdavid K. Hooper, University of CincinnatiAjay K. Israni, University of MinnesotaSamy Riad, University of MinnesotaJunichiro Sageshima, University of California, DavisRon Shapiro, Icahn School of MedicineMichael Seifert, University of Alabama, BriminghamJodi Smith, Seattle Children's HospitalRandall Sung, University of MichiganChristie P. Tomas, University IowaQi Wang, University of MinnesotaPriya S. Verghese, Northwestern University
Language
  • English
Date
  • 2023-05-15
Publisher
  • Frontiers
Publication Version
Copyright Statement
  • © 2023 Rheault, Amaral, Bock, Chambers, Chavers, Ters, Garro, Gbadegesin, Govil, Harshman, Amer, Hooper, Israni, Riad, Sageshima, Shapiro, Seifert, Smith, Sung, Thomas, Wang and Verghese
License
Final Published Version (URL)
Title of Journal or Parent Work
Volume
  • 3
Start Page
  • 1181076
Grant/Funding Information
  • Department of Defense Grant #PR172257.
Abstract
  • Background Focal segmental glomerulosclerosis (FSGS) is a common cause of end-stage kidney disease requiring kidney transplantation and can recur in the allograft in 30-80% of recipients resulting in reduced graft survival. Plasmapheresis has shown efficacy in treating some cases of recurrent FSGS but isolated plasmapheresis has not demonstrated efficacy in preventing recurrent FSGS. Rituximab has had anecdotal success in preventing recurrence in a single center study but has not been studied in combination with plasmapheresis for preventing FSGS recurrence. Methods We are conducting a randomized, controlled, multicenter clinical trial of adult and pediatric kidney transplant recipients with primary FSGS to assess whether plasmapheresis in combination with rituximab prevents recurrent disease post-transplantation. Discussion Rituximab combined with plasmapheresis is a promising, novel therapy to prevent recurrent FSGS, a disease with limited therapeutic options and no consensus guidelines for prevention or treatment.
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Research Categories
  • Health Sciences, Medicine and Surgery

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