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
{"title":"预防性利妥昔单抗预防肾移植后复发局灶节段性肾小球硬化(PRI-VENT FSGS)的随机对照试验:方案和研究设计","authors":"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","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Clinical trial registration: </strong>https://clinicaltrials.gov/ct2/show/NCT03763643, identifier NCT03763643.</p>","PeriodicalId":73091,"journal":{"name":"Frontiers in nephrology","volume":"3 ","pages":"1181076"},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10479749/pdf/","citationCount":"0","resultStr":"{\"title\":\"A randomized controlled trial of preemptive rituximab to prevent recurrent focal segmental glomerulosclerosis post-kidney transplant (PRI-VENT FSGS): protocol and study design.\",\"authors\":\"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\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Clinical trial registration: </strong>https://clinicaltrials.gov/ct2/show/NCT03763643, identifier NCT03763643.</p>\",\"PeriodicalId\":73091,\"journal\":{\"name\":\"Frontiers in nephrology\",\"volume\":\"3 \",\"pages\":\"1181076\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10479749/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Frontiers in nephrology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3389/fneph.2023.1181076\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in nephrology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3389/fneph.2023.1181076","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
A randomized controlled trial of preemptive rituximab to prevent recurrent focal segmental glomerulosclerosis post-kidney transplant (PRI-VENT FSGS): protocol and study design.
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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