一项关于预防性使用利妥昔单抗预防肾移植后复发性局灶节段性肾小球硬化的随机对照试验（PRI-VENT FSGS）：方案与研究设计
A randomized controlled trial of preemptive rituximab to prevent recurrent focal segmental glomerulosclerosis post-kidney transplant (PRI-VENT FSGS): protocol and study design.
作者信息
Rheault Michelle N, Amaral Sandra, Bock Margret, Chambers Eileen Tsai, Chavers Blanche, Ters Mireile El, Garro Rouba, Gbadegesin Rasheed, Govil Amit, Harshman Lyndsay, Amer Hatem, Hooper David K, Israni Ajay K, Riad Samy, Sageshima Junichiro, Shapiro Ron, Seifert Michael, Smith Jodi, Sung Randall, Thomas Christie P, Wang Qi, Verghese Priya S
机构信息
Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States.
Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
出版信息
Front Nephrol. 2023 May 15;3:1181076. doi: 10.3389/fneph.2023.1181076. eCollection 2023.
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.
背景
局灶节段性肾小球硬化（FSGS）是终末期肾病需要肾移植的常见病因，30%-80%的受者移植肾会复发，导致移植肾存活期缩短。血浆置换已显示出对某些复发性FSGS病例有效，但单纯血浆置换在预防复发性FSGS方面未显示出疗效。利妥昔单抗在一项单中心研究中预防复发取得了个案成功，但尚未研究其与血浆置换联合用于预防FSGS复发的情况。
方法
我们正在对患有原发性FSGS的成人和儿童肾移植受者进行一项随机、对照、多中心临床试验，以评估血浆置换联合利妥昔单抗是否能预防移植后疾病复发。
讨论
利妥昔单抗联合血浆置换是一种有前景的新型疗法，可预防复发性FSGS，这是一种治疗选择有限且尚无预防或治疗共识指南的疾病。
临床试验注册
https://clinicaltrials.gov/ct2/show/NCT03763643，标识符NCT03763643。
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