Multicenter trial of everolimus in pediatric renal transplant recipients: results at three year.

Department of Pediatrics, Mattel Children's Hospital, University of California Los Angeles, Los Angeles, CA 90095-1752, USA. rettenger@mednet.ucla.edu

Pediatric transplantation 2008 Jun

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There are few prospective clinical trials of mTOR inhibitors (or proliferation signal inhibitors) combined with CNI inhibitors in de novo pediatric renal transplantation. Results reported here are from a multicenter, open-label study in de novo pediatric renal transplant patients (patients received everolimus with cyclosporine and corticosteroids for one yr, then entered an extension study for a further two yr. Nineteen patients completed the one-yr study, of whom three discontinued study medication. Fifteen of the remaining 16 patients entered the extension study, eight of whom were aged <10 yr (Group 1) and seven were aged 10-16 yr (Group 2). Mean daily dose of everolimus during the first 36 months was 1.53 mg/m(2) BSA. Biopsy-proven acute rejection occurred in three patients in Group 2 and in one patient in Group 1. Biopsy-proven chronic allograft rejection was reported in four patients (two in each age group). Graft survival at one yr was 100%; one patient in Group 2 lost their graft subsequently during the extension. For patients entering the extension, patient survival at three yr was 100%. There were three cases of viral infection, including one case of cytomegalovirus infection. At three yr, mean total cholesterol was 5.5 +/- 0.8 mm/L (213 +/- 31 mg/dL) and four patients received statin therapy. Mean serum creatinine at 36 months was 96 +/- 36 microm/L (1.1 +/- 0.4 mg/dL). This is the first long-term prospective study to demonstrate that a regimen of everolimus, cyclosporine, and corticosteroids provides good efficacy, tolerability, and safety in de novo pediatric renal transplant patients.

Citation

Robert Ettenger, Peter-Friedrich Hoyer, Paul Grimm, Nicholas Webb, Chantal Loirat, John D Mahan, Mark Mentser, Patrick Niaudet, Gisela Offner, R Vandamme-Lombaerts, J Mark Hexham, Everolimus Pediatric Study Group. Multicenter trial of everolimus in pediatric renal transplant recipients: results at three year. Pediatric transplantation. 2008 Jun;12(4):456-63