Randomized Controlled Pilot Study of B Cell-Targeted Induction Therapy in HLA Sensitized Kidney Transplant Recipients.
Ejaz NS, Shields AR, et al.American Journal of Transplantation 2013; 13(12): 3142-3154.
Aims
To conduct a safety/toxicity pilot analysis of four B cell-targeted regimens as a prelude to a larger randomised clinical trial.
Interventions
Patients were administered with rabbit antithymocyte globulin (rATG), rATG and rituximab, rATG and bortezomib or rATG plus rituximab and bortezomib.
Participants
40 high immunologic risk renal transplant recipients.
Outcomes
The outcomes for this study included acute rejection incidence, de novo donor specific antibody production and titer mean fluorescence intensity.
Follow-up
1 year
CET Conclusions
This is a small pilot study in 40 so called high risk recipients of a renal transplant, although there might be some question as to the definition of high risk. The 40 patients were randomised into 4 groups of 10 as receiving induction as described above. There was no real difference in outcome that I can see by the addition of rituximab and/or bortezomib to ATG induction but of course the study is underpowered in terms of efficacy and quite rightly the authors conclude that safety was acceptable and larger trials were justified. However one should note that the use of bortezomib was associated with a number of cases of peripheral neuropathy. Further studies if done would need to define high risk recipients perhaps more stringently.
Data analysis
Available case analysis
Trial registration
ClinicalTrials.gov - NCT00782821