SP792DE NOVO DONOR-SPECIFIC HLA ANTIBODIES AFTER STEROID WITHDRAWAL IN KIDNEY TRANSPLANT RECIPIENTS: A PROSPECTIVE, RANDOMIZED, CONTROLLED, PARALLEL GROUP STUDY. PRELIMINARY RESULTS

Abstract

INTRODUCTION AND AIMS: Steroids represent one of the mainstays of immunosuppression after kidney transplant (KT). Steroid withdrawal reduces metabolic and cardiovascular complications, but whether it increases the risk of acute rejection and the generation of donor‐specific anti‐HLA antibodies (DSA) is currently undetermined. METHODS: In a controlled clinical trial (NCT02284464), a total of 176 KT patients with low immunological risk were recruited to randomly receive either conventional triple immunosuppression: steroids, TAC and MMF versus steroid withdrawal at the third post‐KT month. We compared the incidence of De novo DSA, determined by Luminex Mixed and Luminex Single Antigen (One Lambda® ), and its impact on graft histology in patients with steroid withdrawal at the 3 post‐KT month (after a protocol biopsy) versus patients who continue to receive conventional triple immunosuppression. RESULTS: So far, 68 patients have been randomized (34 per group), with no significant differences in the clinical and demographic characteristics between the groups. The intermediate analysis in those patients who had completed one year of follow‐up (n=28) showed no significant differences in the formation of DSA (0% vs. 0%), nor was there rejection in those patients in whom prednisone was withdrawn after randomization. Patients with triple therapy showed a trend toward better renal function compared to those without steroids at the first post‐KT year (1.29±0.25 vs. 1.56±0.42 mg/dL, P=0.088). HbA1c levels were similar between both group at the first post‐KT year (5.79±0.59 vs. 5.68±0.81%, P=0.734). CONCLUSIONS: The preliminary results show that steroid withdrawal at the 3 month post‐KT seems safe when assessing the appearance of rejection and formation of DSA compared to the patients who continued to receive conventional triple immunosuppression.