A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection.
Halleck, F., et al.Clinical Transplantation 2024; 38(7): e15383.
Aims
The aim of this study was to compare the superiority of imlifidase to therapeutic plasma exchange (PLEX) for the treatment of antibody-mediated rejection (ABMR) in kidney transplant patients.
Interventions
Participants were randomised to receive either imlifidase or PLEX.
Participants
30 kidney transplant recipients (≥18 years of age) with ABMR.
Outcomes
The primary outcome was reduction of DSA levels within 5 days following the start of treatment. Secondary outcomes were DSA levels, graft survival, kidney function, histopathology of biopsies (mRNA levels), number of PLEX sessions required, pharmacokinetics, pharmacodynamics, safety, tolerability, and the immunogenicity profile of imlifidase.
Follow-up
180 days
CET Conclusions
This multicentre open-label RCT compares the use of imlifidase and plasma exchange (PLEX) for the management of biopsy-proven antibody-mediated rejection. 30 patients were randomised 2:1 to imlifidase (with a single dose of IVIg and rituximab) or PLEX (again with a single dose of IVIg and rituximab). Primary endpoint was the maximum reduction in DSA levels in the 5 days following start of treatment which was significantly higher in patients receiving imlifidase. However, DSA levels rebounded rapidly after treatment and there was no difference in clinical outcomes (graft loss, graft function) between groups. Interpretation is challenging as the study is small and no sample size calculation was performed – it is certainly underpowered to show differences in clinical outcomes. The ABMR population was very heterogeneous with variable chronicity. In the population studied with the protocol used, there appears to be limited clinical value to the use of imlifidase in this setting.
Data analysis
Available case analysis
Trial registration
EudraCT number: 2018-000022-66, 2020-004777-49; ClinicalTrials.gov identifier: NCT03897205, NCT04711850