Introduction. Minimizing or sparing potentially nephrotoxic and diabetogenic immunosuppressants could represent an advantage following simultaneous pancreas-kidney transplantation (SPK-Tx).

Purpose. We report here the actual one-year result of a single-center, phase IV study, initiated in 2005, prospectively and randomly evaluating the efficacy and safety of tacrolimus-based (Tac) against sirolimus-based (SRL) immunosuppresssion after SPK-Tx.

Methods. A total of 100 type-1 diabetic patients (mean age 40 years; range 21-56) were included in the study BRD 04/2D, after written informed consent was obtained. All patients received a cadaver SPK-Tx (whole pancreas with portal and enteric drainages) and were randomly assigned (double-blinded) at the time of Tx to continue Tac (n=50; mean age 40.5 years) or to replace Tac by SRL (n=50; mean age 39.4 years) 60-90 days after surgery. Immunosuppression consisted of Thymoglobulin induction for 5 days, mycophenolate mofetil, tacrolimus and low-dose steroid (i.e. withdrawn on day 90). The study design included a 1-year protocol kidney biopsy and a follow-up of 5 years.

Results. The 1-year actual patient, pancreas and kidney survival was 100%, 84% and 100% in the Tac group, and 100%, 88% and 100% in the SRL one (intention to treat analyses). The 1-year freedom from clinical diagnosed and treated kidney and pancreas rejection episode was 90% and 96% in the Tac group, and 86% and 86% in the SRL one. Serum creatinine (¯o;mol/L) and proteinuria (gr/day) at one year was 122 (range 61-289) and 0.32 (0-1.03) in the Tac group, and 115 (57-412) and 0.38 (0-1.5) in the SRL one. At this time period, 96% of patients in the Tac group were still under Tac compared to 54% in the SRL one (p<0.001).

Conclusion. At one year following SPK-Tx, Tac-based immunosuppression as compared to SRL-based immunosuppression was better tolerated with significant less number of patients switched and was associated with less acute rejection episodes and less active immune renal histology features.

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