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

Michelle N. Rheault; Sandra Amaral; Margret Bock; Eileen Tsai Chambers; Blanche Chavers; Mireile El Ters; Rouba Garro; Rasheed Gbadegesin; Amit Govil; Lyndsay Harshman; Hatem Amer; David K. Hooper; Ajay K. Israni; Samy Riad; Junichiro Sageshima; Ron Shapiro; Michael Seifert; Jodi Smith; Randall Sung; Christie P. Thomas; Qi Wang; Priya S. Verghese

doi:10.3389/fneph.2023.1181076

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

Michelle N. Rheault, Sandra Amaral, Margret Bock, Eileen Tsai Chambers, Blanche Chavers, Mireile El Ters, Rouba Garro, Rasheed Gbadegesin, Amit Govil, Lyndsay Harshman, …

Frontiers in Nephrology, Vol.3, 1181076

05/15/2023

DOI: 10.3389/fneph.2023.1181076

PMCID: PMC10479749

PMID: 37675355

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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. Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT03763643 , identifier NCT03763643.

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Title: Subtitle: A randomized controlled trial of preemptive rituximab to prevent recurrent focal segmental glomerulosclerosis post-kidney transplant (PRI-VENT FSGS): protocol and study design
Creators: Michelle N. Rheault
Sandra Amaral
Margret Bock
Eileen Tsai Chambers
Blanche Chavers
Mireile El Ters
Rouba Garro
Rasheed Gbadegesin
Amit Govil
Lyndsay Harshman
Hatem Amer
David K. Hooper
Ajay K. Israni
Samy Riad
Junichiro Sageshima
Ron Shapiro
Michael Seifert
Jodi Smith
Randall Sung
Christie P. Thomas
Qi Wang
Priya S. Verghese
Resource Type: Journal article
Publication Details: Frontiers in Nephrology, Vol.3, 1181076
DOI: 10.3389/fneph.2023.1181076
PMID: 37675355
PMCID: PMC10479749
NLM abbreviation: Front Nephrol
ISSN: 2813-0626
eISSN: 2813-0626
Grant note: DOI: 10.13039/100000090, name: Congressionally Directed Medical Research Programs
Language: English
Date published: 05/15/2023
Academic Unit: Nephrology, Dialysis and Transplantation; Stead Family Department of Pediatrics; Iowa Neuroscience Institute; Radiation Oncology; Obstetrics and Gynecology; Nephrology; Internal Medicine
Record Identifier: 9984410795602771

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