title: Multicenter trial of everolimus in pediatric renal transplant recipients: results at three year.
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 (<or=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 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.
authors.affiliation: Department of Pediatrics, Mattel Children's Hospital, University of California Los Angeles, Los Angeles, CA 90095-1752, USA. rettenger@mednet.ucla.edu
authors.forename: Robert
authors.initials: R
authors.lastname: Ettenger
authors.forename: Peter-Friedrich
authors.initials: PF
authors.lastname: Hoyer
authors.forename: Paul
authors.initials: P
authors.lastname: Grimm
authors.forename: Nicholas
authors.initials: N
authors.lastname: Webb
authors.forename: Chantal
authors.initials: C
authors.lastname: Loirat
authors.forename: John D
authors.initials: JD
authors.lastname: Mahan
authors.forename: Mark
authors.initials: M
authors.lastname: Mentser
authors.forename: Patrick
authors.initials: P
authors.lastname: Niaudet
authors.forename: Gisela
authors.initials: G
authors.lastname: Offner
authors.forename: R
authors.initials: R
authors.lastname: Vandamme-Lombaerts
authors.forename: J Mark
authors.initials: JM
authors.lastname: Hexham
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D001706:Biopsy; D002648:Child; D016572:Cyclosporine / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation / Q000379:methods*; D008297:Male; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000068338:Everolimus; D020123:Sirolimus