Introduction. We report here the actual 5-year results of a prospective and randomized steroid avoidance study conducted in 6 university hospitals in adult patients receiving a first kidney transplant from deceased donors.

Patients and methods. A total of 197 patients received anti-Jurkat rabbit-ATG induction, mycophenolate mofetil, delayed cyclosporine and were randomly assigned before transplantation to receive at least 6-month corticosteroid protocol (+CS; n=99) or no corticosteroid at all (-CS; n=98). The study was originally designed for efficacy and safety during 5-year follow-up of all included patients.

Results. The 1-year and actual 5-year graft survival was 93.2% and 81% in the +CS group, and 95% and 87% in the -CS group (p=. 276). The 1-year and 5-year freedom from clinical diagnosed rejection episode was 87% and 82% in the +CS group, and 74.5% and 74.5% in the -CS group (p=.144), with clinically relevant more late first rejection episodes occurring in the +CS group. The 5-year freedom from biopsy-proven rejection was 89% vs. 84%, respectively (p=.227). A significant lower 5-year graft survival was observed in patients experiencing rejection episodes in the +CS group compared to the -CS group (55.6% vs. 92.0%; p=.005), with 8/18 vs. 2/25 graft losses after a rejection event. The 5-year renal function measured by serum creatinine and e-GFR was comparable in both groups: 159 vs. 145 ¯o;mol/L, and 53.5 vs. 56.6 mL/min, respectively. Of interest, patients in the +CS group developed more insulin-depending NODAT, dyslipidemia and malignancies.

Conclusion. Similar to other steroid avoidance studies, we observed more early acute rejection events in the -CS group. However, pattern of rejection events was different; all rejections in -CS group occurred early after Tx, completely resolved and did not impair long-term renal function. In contrast, in the +CS group, rejection events occurred late after Tx and concerned patients were at high risk for subsequent graft failure. When aiming for steroid minimization, complete avoidance is a safe and efficacious strategy for treatment of primary kidney transplant patients under present evaluated induction and maintenance immunosuppression.

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