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

Pediatric Transplantation - Tập 12 Số 4 - Trang 456-463 - 2008
Robert B. Ettenger1, Peter F. Hoyer2, Paul C. Grimm3, Nicholas J.A. Webb4, Chantal Loirat5, John D. Mahan6, Mark Mentser7, Patrick Niaudet8, G. Offner9, R. Vandamme‐Lombaerts10, J. Mark Hexham11
1Department of Pediatrics, Mattel Children's Hospital, University of California Los Angeles, Los Angeles, CA, USA
2Department of Pediatric Nephrology, Universitätsklinikum Essen, Essen, Germany
3Department of Pediatric Nephrology, University of California, San Diego, La Jolla, USA
4Royal Manchester Children’s Hospital, Manchester, UK
5Department of Nephrology, Assistance Publique-Hopitaux de Paris, Hopital Robert Debre, Paris, France
6Department of Nephrology, Children's Hospital, Columbus, OH, USA
7Division of Nephrology, Children's Hospital, Los Angeles, USA
8Hôpital Necker, Paris, France
9Medizinische Hochschule Hannover, Hannover, Germany
10U.Z. Gasthuisberg, Leuven, Belgium
11Novartis Pharmaceuticals, East Hanover, NJ, USA

Tóm tắt

Abstract:  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/m2 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 μm/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.

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Pediatric Transplantation

Tập 12 Số 4

456-463

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