*Purpose: mTOR inhibitors (mTORi) allow calcineurin-inhibitor reduction without loss of efficacy and may improve allograft-transplant outcomes. However, the safety of this protocol in high-immunological risk kidney transplants is not clear.

*Methods: To shed light on this issue, we examined 106 consecutive kidney transplant only with a baseline calculated panel reactive antibody (PRA) >= 20% or Donor Specific Antibody (DSA) prior to the transplant from Jan 2016 to December 2020 in our unit. Immunosuppression was based on CNI (tacrolimus), steroids and alternatively mycophenolic acid (MPA; n = 20), or mTORi (either everolimus or sirolimus, n = 96, target trough levels 4-8 ng/mL). Patients received methylprednisonlone and thymoglobulin induction. Outcome measures included a one-year analysis of patient and renal allograft survival and acute rejection incidence (biopsy-proven acute rejection – BPAR).

*Results: Demographic and immunological risk profiles were similar in both groups. Cumulative patient and graft survival were not significantly different in the two groups (mTORi: 82.5% and MPA 84% log-rank test p = 0.867). Cumulative incidence of BPAR was not significantly different ( mTORi: 10% and MPA: 17%; log-rank test p = 0.4).

*Conclusions: This single-center retrospective cohort one-year analysis suggests that in hypersensitized kidney transplant recipients receiving tacrolimus-based immunosuppressive therapy, similar clinical outcomes may be obtained using mTOR inhibitors compared to mycophenolate.

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