Early Corticosteroid Avoidance in Kidney Transplant Recipients Receiving ATG‐F Induction: 5‐Year Actual Results of a Prospective and Randomized Study

One hundred ninety‐seven patients received anti‐T‐lymphocyte globulins Fresenius, mycophenolate mofetil and delayed cyclosporine, and were randomized to ≥6‐month corticosteroids (+CS; n = 99) or no CS (−CS; n = 98). One‐ and five‐year actual graft survival (censored for death) was 93.2% and 86.4% in the +CS group versus 94.9% and 89.8% in the −CS group (5‐year follow‐up, p = 0.487). Freedom from clinical rejection was 86.9% and 81.8% versus 74.5% and 74.5% (p = 0.144), respectively, at 1 and 5 years; 5‐year freedom from biopsy‐proven rejection was 88.9% versus 83.7% (p = 0.227). More late first rejections occurred in the +CS group. Significantly lower 5‐year graft survival in patients experiencing rejection was observed for +CS (55.6% vs. 92.0%; p = 0.005) with 8/18 versus 2/25 graft losses. Renal function at 5 years was stable and comparable (median serum creatinine, 159 vs. 145 µmol/L; creatinine clearance, 53.5 vs. 56.6 mL/min). More +CS patients developed diabetes, dyslipidemia and malignancies. Rejections in −CS patients occurred early after transplantation and did not impair long‐term renal function. In patients receiving CS, rejections occurred later and with a higher risk for subsequent graft failure. A similar and not inferior 5‐year efficacy profile and a reduced morbidity were observed in CS‐free patients compared to patients who received CS for at least 6 months. This study identifies similar long‐term graft and patient survival in recipients of primary kidney transplants independently if steroids are avoided from the day of surgery or withdrawn thereafter; however, the pattern and late impact of acute rejection, as well as the safety profile, differ between these two groups.