This is a three year follow-up of a prospective, randomized controlled trial (RCT) to determine the safety and efficacy of induction with rabbit antithymocyte globulin (rATG) compared to IL2RA in a moderate to high risk transplant population under modern immunosuppression.

Methods: Three-year follow-up of a single-center, open-labeled, RCT at a large, racially diverse, transplant center. Patients were randomized to receive IL2RA versus rATG for induction in combination with tacrolimus, MMF and corticosteroids. Patients were risk-stratified to ensure equality between groups for race, repeat transplant, PRA>20% and CIT>24hrs.

Results: 200 patients (n=98 in the IL2RA group and n=102 in the rATG group) were enrolled (3 patients in the IL2RA group were excluded in the 3 year analysis following receipt of a pancreas transplant). Baseline demographics were the same in each group (Table 1). BPAR rates after 1-year were significantly lower in the rATG group compared to the IL2RA group (2% vs.7%, p=0.03, Table 2). Rejections occurring after 1 year resulted predominantly following non-adherence or sub-therapeutic immunosuppression. At 3 years, the incidence of BKN was higher in the rATG group (8% vs. 1%, p=0.04). Subgroup analysis based on race demonstrated no differences in infections with a strong trend towards lower rejection rates in black patients in the rATG group; whereas non-black patients experienced a higher incidence in bacterial infections requiring hospitalization in the IL2RA group and more CMV infections in the rATG group [Table 3].

Conclusions: rATG induction provides improved protection against early and late acute rejection, predominantly in black renal transplant recipients, while IL2RA yielded an increased risk of bacterial infections in non-black recipients.

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