Abstract

Steroids have been a cornerstone in renal transplant immunosuppression despite cardiovascular risk and growth impairment in children. New immunosuppressive drugs have allowed early withdrawal or even complete avoidance of steroids. To evaluate a new immunosuppressive protocol with early withdrawal of steroids in a pediatric renal transplant population, we initiated a prospective study in recipients >1 year old who showed low immunologic risk was started. Group A (n = 12) received decreasing doses of steroids until day posttransplant 7 under a regimen of Tacrolimus (FK) and mycophenolate mofetil (MMF). Group B (n = 11) were controls treated with steroids, cyclosporine and azathioprine. In both groups, induction therapy included basiliximab. We evaluated anthropometric and biochemical variables, acute rejection episodes (ARE), and cytomegalovirus (CMV) infection. Mean values and variations for continuous variables were calculated at months 1 and 3 for comparison at the same time using student's t-test and regresion analysis. We obtained mean values at months 1, 3, and 6 for groups A and B of creatinine clearance (mL/min): 86.2 versus 107.4; 76.9 versus 96.6; 73.3 versus 97.9 (P < .05); hematocrit (%) was 27.4 versus 31.8; 29.3 versus 33.9; 32.9 versus 34.3% (P < .05); total cholesterol (mg/dL), 148 versus 195, 139 versus 85, 142 versus 174 (P < .05); creatinine clearance decreased in both groups during follow-up with a smaller slope among group A (P < .05). No differences were observed between the groups in Z height, diastolic and systolic blood pressures at 6 months of follow-up. Serum total cholesterol mean levels at months 1, 3, and 6 were significantly lower among the group withdrawn from steroids (P < .05). Plasma bicarbonate levels were lower among group A than B; there was no difference in blood glucose levels. No AREs and no difference in CMV infections were observed. In conclusion, early withdrawal of steroids with FK and MMF was not associated with a higher incidence of either ARE or CMV infection. Lower levels of cholesterol could imply a reduced cardiovascular risk. Longer follow-up is needed to evaluate the impact of this therapy on renal function and linear growth. © 2008 Elsevier Inc. All rights reserved.