A randomized controlled trial of preemptive rituximab to prevent recurrent focal segmental glomerulosclerosis post-kidney transplant (PRI-VENT FSGS): protocol and study design.Rheault, M. N., et al
Frontiers in Nephrology 2023; 3: 1181076.
The investigators aim to assess if rituximab primitively with plasmapheresis reduced recurrence of FSGS at 1 year compared to plasma pheresis alone.
The interventional arm will receive plasmapheresis with rituximab and the control arm will receive plasma pheresis only.
160 children or adults with biopsy proven FSGS or MCD receiving living or deceased donor kidney for their 1st, 2nd or 3rd transplant. Patients with monogenic FSGS or secondary cause of FSGS and those who received rituximab 1 year prior to transplant will be excluded.
The primary outcome is FSGS recurrence at 1 year. The secondary outcomes are: time to FSGS recurrence, graft survival, patient survival, graft function (eGFR), acute rejection and proportion with CD19+ <1% at 1 month, 6 months, and 12 months.
12 months posttransplantation.
The investigators present their protocol for the first randomised multicentre trial of its kind, done so based on a lack of clarity from a meta-analysis of smaller retrospective studies on rituximab in FSGS recurrence. The methodology has some limitations, firstly it is not blinded, which given it is only a single dose of rituximab pre-transplant, blinding could have relatively easily been incorporated. The study has been powered based on paediatric FSGS recurrence rates which are slightly higher than that of the adult population, meaning there could be a degree of underpowering in the design. This may be compounded by their inclusion of minimal change disease which they have predicted to have the same recurrence rate of FSGS based on a single small retrospective cohort study. There is no genetic testing done in the adult population, which could introduce bias given genetic nephrotic syndromes are highly unlikely to recur. However, the randomisation is robust and done centrally, with the investigators confident that if recruitment target is reached the study will be a success.
ClinicalTrials.gov - NCT03763643