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

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

Front Nephrol. 2023 May 15:3:1181076. doi: 10.3389/fneph.2023.1181076. eCollection 2023.

Authors

Michelle N Rheault¹, Sandra Amaral², Margret Bock³, Eileen Tsai Chambers⁴, Blanche Chavers¹, Mireile El Ters⁵, Rouba Garro⁶, Rasheed Gbadegesin⁴, Amit Govil⁷, Lyndsay Harshman⁸, Hatem Amer⁵, David K Hooper^{9

10}, Ajay K Israni^{11

12}, Samy Riad¹², Junichiro Sageshima¹³, Ron Shapiro¹⁴, Michael Seifert¹⁵, Jodi Smith¹⁶, Randall Sung¹⁷, Christie P Thomas¹⁸, Qi Wang¹⁹, Priya S Verghese²⁰

Affiliations

¹ Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States.
² Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
³ Department of Pediatrics, Children's Hospital of Colorado, Denver, CO, United States.
⁴ Department of Pediatrics, Duke University, Durham, NC, United States.
⁵ Department of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, United States.
⁶ Department of Pediatrics, Emory University, Atlanta, GA, United States.
⁷ Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, United States.
⁸ Department of Pediatrics, University of Iowa, Iowa, IA, United States.
⁹ Division of Nephrology and Hypertension, Cincinnati Children's Hospital, Cincinnati, OH, United States.
¹⁰ Department of Pediatrics, University of Cincinnati, Cincinnati, OH, United States.
¹¹ The Kidney Center at Hennepin Healthcare, Hennepin Health, Minneapolis, MN, United States.
¹² Department of Medicine, University of Minnesota, Minneapolis, MN, United States.
¹³ Department of Surgery, University of California, Davis, Davis, CA, United States.
¹⁴ Department of Surgery, Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY, United States.
¹⁵ Heersink School of Medicine, Department of Pediatrics, School of Medicine, University of Alabama, Birmingham, AL, United States.
¹⁶ Department of Pediatrics, Seattle Children's Hospital, Seattle, WA, United States.
¹⁷ Department of Surgery, University of Michigan Health, Ann, Arbor, MI, United States.
¹⁸ Department of Internal Medicine, University of Iowa, Iowa City, IA, United States.
¹⁹ Clinical and Translational Science Institute, University of Minnesota, Minneapolis, MN, United States.
²⁰ Department of Pediatrics, Northwestern University, Ann & Robert H. Lurie Children's Hospital, Chicago, IL, United States.

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.

Keywords: focal segmental glomerulosclerosis; kidney transplant; nephrotic syndrome; plasmapheresis; recurrent disease.

Associated data

ClinicalTrials.gov/NCT03763643

Grants and funding

Department of Defense Grant #PR172257. The US Department of Defense had no role in the design of the study or the collection, analysis, or interpretation of data.