*Purpose: A prospective, randomized controlled trial has shown comparable rates of biopsy-proven rejection (BPAR) between LCPT and IR-Tac treated renal transplant recipients. This analysis aims to examine in more detail the BPAR severity, kidney function, and outcomes in those with BPAR.

*Methods: A post-hoc analysis of 536 kidney transplant recipients from a large Phase 3 study of LCPT vs. IR-Tac in de novo kidney transplant recipients was conducted. Biopsy reports evaluated by central pathologists were reviewed to determine rejection severity. “Rejection creatinine” was defined as the last creatinine immediately prior to the date of biopsy, and “nadir creatinine” was the average of the 3 lowest creatinine concentrations within 6 months of the BPAR.

*Results: Demographic and rejection characteristics of the 64 LCPT (24.2%) and 80 IR-Tac (29.5%) patients who experienced BPAR are shown in Table 1. Severity of BPAR episodes were comparable between the groups. Similarly, renal function during and post BPAR was similar for both groups. Kaplan-Meier analysis of the incidence of BPAR is shown in Figure 1.

*Conclusions: These data indicate that incidence of rejection and rejection characteristics between LCPT and IR-Tac are similar with regard to severity, impact on renal function, and impact on overall outcomes.

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