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Multicenter trial of everolimus in pediatric renal transplant recipients: Results at three year
Author(s) -
Ettenger Robert,
Hoyer PeterFriedrich,
Grimm Paul,
Webb Nicholas,
Loirat Chantal,
Mahan John D.,
Mentser Mark,
Niaudet Patrick,
Offner Gisela,
VandammeLombaerts R.,
Hexham J. Mark
Publication year - 2008
Publication title -
pediatric transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.457
H-Index - 69
eISSN - 1399-3046
pISSN - 1397-3142
DOI - 10.1111/j.1399-3046.2007.00832.x
Subject(s) - medicine , everolimus , transplantation , regimen , surgery , multicenter trial , creatinine , prospective cohort study , biopsy , clinical trial , kidney transplantation , single center , gastroenterology , randomized controlled trial , multicenter study
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 (≤16 yr), in which 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 m m /L (213 ± 31 mg/dL) and four patients received statin therapy. Mean serum creatinine at 36 months was 96 ± 36 μ m /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.