Infliximab Induction Lacks Efficacy and Increases BK Virus Infection in Deceased Donor Kidney Transplant Recipients.Hricik, D., et al.
Journal of the American Society of Nephrology 2022 [record in progress].
The aim of this study was to investigate the efficacy of intravenous infliximab on kidney transplant survival and function.
Participants were randomised to either the infliximab (intervention) group or saline (control) group.
225 deceased donor kidney transplant candidates (>18 years).
The primary outcome was the assessment of mean 24-month estimated glomerular filtration rate (eGFR).
This is a well-written report of a multicentre, double-blind, randomised controlled trial. Recipients of deceased-donor kidney transplant were randomised to receive infliximab or placebo in addition to the standard immune suppression with ATG, tacrolimus, mycophenolate and prednisolone. 225 patients were included and randomised using a computer-generated scheme. The primary outcome was estimated GFR at 24 months after transplantation and the target was 300 patients given the first power calculation. However, after 3 years of enrolment, it was clear that it would not be possible to enroll the target population and complete 2 years follow up. The power calculation was re-done using an updated estimate for the standard deviation and a minimal significant difference in GFR of 8ml/min. There was no significant difference in estimated GFR at 24 months after transplantation. There was no significant difference in drug doses (tacrolimus, mycophenolate, ATG, prednisolone) between the 2 arms of the study. There was no significant difference in the rate of delayed graft function. There was a significant increase in BK viraemia with infliximab, and the rate of BKV nephropathy showed a very strong trend towards significance. In this well-conducted study, the addition of infliximab to standard immune suppression did not decrease DGF or improve GFR at 24 months, but did increase rates of BK viraemia and would likely increase rates of BK nephropathy if used in larger numbers.
ClinicalTrials.gov - NCT02495077