Eculizumab Therapy for Chronic Antibody-Mediated Injury in Kidney Transplant Recipients: A Pilot, Randomized-Controlled Trial.
Kulkarni S, Kirkiles-Smith NC, et al.American Journal of Transplantation 2016 [record in progress].
Aims
To determine whether prolonged treatment with eculizumab would stabilize graft function in kidney transplant recipients that had developed de novo donor specific antibody (DSA).
Interventions
Participants were randomized to receive either eculizumab for 6-months followed by observation for 6-months (treatment group), versus observations over a 12-month period (control group).
Participants
16 patients aged 18-65 years, > 6-months from their first kidney transplant with a measured de novo DSA of greater than Mean Fluorescence Intensity (MFI)>1100.
Outcomes
The primary outcome measured was the difference in percent change of estimated glomerular filtration rate trajectory over time. Secondary outcomes included 1-year graft survival, incidence of biopsy-proven acute rejection, incidence of treatment failure and expression of endothelial cell associated transcripts (ENDATs).
Follow-up
12 months
CET Conclusions
This was a pilot study of some interest. It was powered for a significance level of 0.10, with 2:1 randomisation given the cost of the study drug (eculizumab). Only 16 patients were included in the study, over an enrollment period of 3 and a half years. Treatment with eculizumab was associated with stabilization of renal function compared to no treatment in patients with de novo DSA. The study is limited by its size and the variability in the trajectory of renal function of the included patients. It is too small to really comment on the impact of the study drug on safety outcomes, such as infection rates.
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinicaltrials.gov - NCT01327573