title: Three-yr safety and efficacy of everolimus and low-dose cyclosporine in de novo pediatric kidney transplant patients.
abstract: The three yr results of a multicenter trial in de novo pediatric KT treated with a proliferative signal inhibitor and low dose CNI are presented. Thirty-seven children (9.1 ± 5 yr old) received basiliximab, cyclosporine A (CyA C2:1400 ng/mL), (MMF C0:1.5-3 μg/mL), and prednisone. Three wk later everolimus was started (C0:5-10 ng/mL), CyA was reduced (C2:600 ng/mL after 90 days 300 ng/mL), and MMF discontinued. During the three-yr period patient and graft survivals were 96%. One patient died for causes unrelated to the immunosuppression. Cumulative acute rejection rate including protocol and indication biopsies was 21.9%. None of the patients had signs of chronic humoral rejection. Incidence of dnDSA was 5%, 11%, and 22% at one, two, and three yr post-transplant, respectively. Mean glomerular filtration rate measured at one yr and three yr post-transplant was 105.5 ± 31 and 110.7 ± 27 mL/min/1.73 m(2), respectively. A growth velocity of 7.7 ± 6.7 cm/yr was achieved with positive catch-up growth. No malignancy or post-transplant lymphoproliferative diseases were diagnosed. In conclusion, the treatment based on basiliximab induction, everolimus, low-dose cyclosporine, and low-dose prednisone leads to good long-term efficacy in de novo pediatric KT recipients.
authors.affiliation: Department of Medical Science and Community Health, University of Milan, Milan, Italy; Division of General and Vascular Surgery, St. Joseph Hospital, Multimedica I.R.C.C.S., Milan, Italy.
authors.forename: Mariano
authors.initials: M
authors.lastname: Ferraresso
authors.forename: Mirco
authors.initials: M
authors.lastname: Belingheri
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ginevri
authors.forename: Luisa
authors.initials: L
authors.lastname: Murer
authors.forename: Luca
authors.initials: L
authors.lastname: Dello Strologo
authors.forename: Massimo
authors.initials: M
authors.lastname: Cardillo
authors.forename: Angelica
authors.initials: A
authors.lastname: Parodi
authors.forename: Giulia
authors.initials: G
authors.lastname: Ghirardo
authors.forename: Isabella
authors.initials: I
authors.lastname: Guzzo
authors.forename: Annalisa
authors.initials: A
authors.lastname: Innocente
authors.forename: Luciana
authors.initials: L
authors.lastname: Ghio
mesh_terms: D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D006084:Graft Rejection / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D016030:Kidney Transplantation / Q000401:mortality; D008297:Male; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011241:Prednisone / Q000627:therapeutic use; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D000068338:Everolimus; D009173:Mycophenolic Acid; D011241:Prednisone; D020123:Sirolimus
keywords: acute rejection; cyclosporine; donor specific antibodies; everolimus; long term results; pediatric kidney transplantation