Clinical everolimus experience in pediatric renal transplant patients.

OBJECTIVE: Everolimus is a potent immunosuppressive agent that has antiproliferative activities. This study sought to share our experience among renal transplanted children who required conversion from calcineurin inhibitors (CNIs) to the mammalian target of rapamycin inhibitor everolimus.

PATIENTS AND METHODS: Exclusion criteria were multiple organ transplantations, loss of a previous graft due to immunologic reasons, receipt of an organ donated after cardiac death, donor age <5 years or >65 years, panel reactive antibodies >25%, platelets <75,000/mm(3), absolute neutrophil count of <1,500/mm(3), leucocytes <2,500/mm(3), hemoglobin <6 g/dL, severe liver disease, cold ischemia time >40 hours or anti-HLA panel-reactive antibodies >50%.

RESULTS: Eighteen renal transplant patients (10 male, 8 female) underwent conversion to everolimus from CNI: 8 from cyclosporine (CsA) and 10 from tacrolimus. The mean age was 12.6 ± 0.9 years and the mean body mass index 21.8 ± 1.7 kg/m(2). The mean 2-hour postdose level of CsA before conversion was 671 ± 142 ng/mL; the patients on tacrolimus showed a mean trough concentration of 4.5 ng/mL. Six (33,3%) were taking mycophenolate mofetil and 12 (66.6%) enteric-coated mycophenolate sodium. No significant changes were observed in either hepatic functions, serum lipids, or hemograms. There was no mortality or graft loss. The mean level of serum creatinine was 1.3 ± 0.7 mg/dL before and 1.09 ± 0.6 mg/dL after conversion. Proteinuria observed in only 1 patient was well controlled with angiotensin-converting enzyme inhibitor therapy. All patients responded to statin therapy. One patient developed unilateral lower extremity edema and 1 a lymphocele. Although there were 3 cases (14%) of biopsy-confirmed acute rejection, there was no mortality or graft loss.

CONCLUSIONS: Everolimus conversion has become an excellent choice, offering safety and efficacy with good outcomes.