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

Autor:	Rheault MN; Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States., Amaral S; Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States., Bock M; Department of Pediatrics, Children's Hospital of Colorado, Denver, CO, United States., Chambers ET; Department of Pediatrics, Duke University, Durham, NC, United States., Chavers B; Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States., Ters ME; Department of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, United States., Garro R; Department of Pediatrics, Emory University, Atlanta, GA, United States., Gbadegesin R; Department of Pediatrics, Duke University, Durham, NC, United States., Govil A; Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, United States., Harshman L; Department of Pediatrics, University of Iowa, Iowa, IA, United States., Amer H; Department of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, United States., Hooper DK; Division of Nephrology and Hypertension, Cincinnati Children's Hospital, Cincinnati, OH, United States.; Department of Pediatrics, University of Cincinnati, Cincinnati, OH, United States., Israni AK; The Kidney Center at Hennepin Healthcare, Hennepin Health, Minneapolis, MN, United States.; Department of Medicine, University of Minnesota, Minneapolis, MN, United States., Riad S; Department of Medicine, University of Minnesota, Minneapolis, MN, United States., Sageshima J; Department of Surgery, University of California, Davis, Davis, CA, United States., Shapiro R; Department of Surgery, Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY, United States., Seifert M; Heersink School of Medicine, Department of Pediatrics, School of Medicine, University of Alabama, Birmingham, AL, United States., Smith J; Department of Pediatrics, Seattle Children's Hospital, Seattle, WA, United States., Sung R; Department of Surgery, University of Michigan Health, Ann, Arbor, MI, United States., Thomas CP; Department of Internal Medicine, University of Iowa, Iowa City, IA, United States., Wang Q; Clinical and Translational Science Institute, University of Minnesota, Minneapolis, MN, United States., Verghese PS; Department of Pediatrics, Northwestern University, Ann & Robert H. Lurie Children's Hospital, Chicago, IL, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in nephrology [Front Nephrol] 2023 May 15; Vol. 3, pp. 1181076. Date of Electronic Publication: 2023 May 15 (Print Publication: 2023).
DOI:	10.3389/fneph.2023.1181076
Abstrakt:	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. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03763643, identifier NCT03763643. Competing Interests: Author MR is a site PI for unrelated clinical trials funded by Chinook, Kaneka, Travere, Reata, Sanofi and a consultant for Visterra. Author PV is a site PI for unrelated clinical trials funded by Akebia, Allosure, Otsuka, Pharmacosmos and Viracor and a consultant for NS Pharma. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Rheault, Amaral, Bock, Chambers, Chavers, Ters, Garro, Gbadegesin, Govil, Harshman, Amer, Hooper, Israni, Riad, Sageshima, Shapiro, Seifert, Smith, Sung, Thomas, Wang and Verghese.)
Databáze:	MEDLINE
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