An extension of the RITUX-ERAH study, multicenter randomized clinical trial comparing rituximab to placebo in acute antibody-mediated rejection after renal transplantation.Bailly, E., et al.
Transplant International 2020 [record in progress].
The aim of this study was to report the 7 year results of the RITUX-ERAH study, a randomized trial that investigated the effect of rituximab in the treatment of active antibody-mediated rejection (ABMR) in recipients of kidney transplant.
Participants were randomly assigned to the rituximab group or the placebo group.
38 renal transplant recipients.
The outcomes of interest were death-censored graft survival, renal fuction, evolution of anti-HLA sensitization, and the incidence of infectious or neoplastic complications.
This paper reports the 7-year results from the RITUX-ERAH study, a randomised controlled trial of rituximab in the treatment of acute antibody-mediated rejection in renal transplantation. The results confirm earlier findings that rituximab had no effect on renal function or the risk of graft loss over standard care (IvIg, steroid and plasma exchange). The authors note that six of 27 patients receiving rituximab developed cancers, with no malignancy seen in the control arm, although with a small sample size this does not reach statistical significance. The study is limited by the initial sample size of just 38 patients, as well as the high rate of crossover during follow-up that made only a per-protocol analysis possible (27/38 had at least one rituximab infusion). It is therefore difficult to draw any firm conclusions on these data.
ClinicalTrials.gov - NCT01350882