Prospective randomized controlled trial of rabbit antithymocyte globulin compared with IL-2 receptor antagonist induction therapy in kidney transplantation.
Pilch NA, Taber DJ, Moussa O, et al.Annals of Surgery 2014; 259 (5): 888-893.
Aims
To compare the efficacy and safety of interleukin-2 receptor antagonists (IL-2RA) and rabbit antithymocyte globulin (RATG) within a racially diverse population of kidney transplant recipients.
Interventions
Participants received either IL-2RA or RATG in combination with tacrolimus, mycophenolate mofetil, and corticosteroids.
Participants
200 adult renal transplant recipients.
Outcomes
The primary outcome was the incidence of acute rejection episodes. The secondary outcomes included biopsy proven acute rejection (BPAR), steroid resistant BPAR, serum creatinine concentrations, glomerular filtration rate, one year death censored graft survival and patient survival.
Follow-up
1 year.
CET Conclusions
This well-designed open-label study compares IL2 antibody induction with rabbit ATG in a group of relatively high-risk renal transplant recipients. Whilst no significant differences in acute rejection rates or graft function were seen overall, a planned subgroup analysis demonstrated a marginally significant reduction in acute rejection rates in black recipients. Also of interest, there was a significantly lower risk of BK virus nephropathy seen in the IL2RA group. These data do suggest that for most recipients receiving a modern Tac and MMF-based immunosuppressive regimen, IL2RA may be effective, and even preferable, to lymphocyte depleting agents. The caveat to this is that no power calculation or 95% confidence intervals are reported, so it is difficult to determine if the study has sufficient power to truly demonstrate no difference between the study arms.
Data analysis
Available case analysis
Trial registration
ClinicalTrials.gov – NCT00859131