Pediatric Kidney Transplantation Followed by De Novo Therapy With Everolimus, Low-Dose Cyclosporine A, and Steroid Elimination: 3-Year Data

Background. Acute rejections and infections continue to cause substantial problems for pediatric kidney transplant (KTX) patients because defining an immunosuppressive protocol capable of preventing both has been challenging. Previously, we initiated a prospective trial to evaluate an immunosuppressive regimen designed to achieve this goal. Herein, we present the results of the 3-year follow-up of this trial. Methods. After KTX, 20 children (median age 12 years, range 1-17 years) received basiliximab, cyclosporine A (CsA) (trough-level=C0 200-250 ng/mL), and prednisolone. Two weeks post-KTX, everolimus (1.6 mg/m(2)/day) treatment was started (C0 4-6 ng/mL), and the CsA dose was reduced by 50% (C0 75-100 ng/mL, after 6 months: C0 50-75 ng/mL). Prednisolone treatment was gradually withdrawn and was completely stopped at 9 months post-KTX. Results. There was no loss of follow-up and no graft or patient loss during the 3-year period. Indication biopsies showed no acute rejection (Banff >= IA). One of the patients had signs of chronic humoral rejection. Mean glomerular filtration rate measured at 1 year and 3 years post-KTX was 71 +/- 25 and 61 +/- 27 mL/min/1.73 m(2), respectively. In patients transitioned to adult care, mean glomerular filtration rate at 3 years was 49 +/- 13 mL/min/1.73 m(2) (P<0.05). No cases of posttransplant lymphoproliferative disorder posttransplant lymphoproliferative disorder or polyoma nephropathy were diagnosed. After 3 years, 17 of 20 patients remained on the original immunosuppressive regimen. Conclusions. A treatment regimen consisting of de novo immunosuppression with basiliximab, CsA, and prednisolone, followed by treatment with everolimus and low-dose CsA combined with steroid withdrawal may be a promising therapy after pediatric KTX.