BACKGROUND Early steroid withdrawal (ESW) can improve lipid and hemodynamic profiles without severe acute rejection (AR) events in renal transplant patients. Our objective was to evaluate the effects of ESW on the frequency and severity of AR. METHODS A randomized, open-label, controlled clinical trial was performed on renal transplant recipients with a follow-up of 12 months. In the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth day post transplantation. In the Control group, patients continued with steroid treatment. All patients were over 18 years of age with panel reactive antibody (PRA) class I and II HLA <20%. RESULTS In total, 71 patients, 37 in the ESW group (52.1%) and 34 in the Control group (47.9%), had comparable AR incidences at the end of the follow-up (16% vs 15%) (NS) (RR = 1.20, 95% CI = 0.32-3.33). Although renal graft survival was similar between the ESW and Control groups (87% vs 94%), renal function was superior in the ESW group (85 vs 75 mL/min). Additionally, hypertension was less frequent in the ESW group (3% vs 35%), requiring the use of fewer antihypertensives (8% vs 50%). CONCLUSIONS ESW was also associated with better blood pressure control and similar AR risk. The ESW group exhibited stable renal function.