title: De novo therapy with everolimus, low-dose ciclosporine A, basiliximab and steroid elimination in pediatric kidney transplantation.
abstract: The number of acute rejections and infections after pediatric kidney transplantation (KTX) could not be reduced in the last years. To reduce these events, we investigated a new immunosuppressive protocol in a prospective trial. After KTX, 20 children (median age 12 years, range 1-17) were initially treated with Basiliximab, ciclosporine A (CsA) (trough-level = C0 200-250 ng/mL) and prednisolone. After 2 weeks, CsA dose was reduced to 50% (C0 75-100 ng/mL, after 6 months: 50-75 ng/mL) and everolimus (1.6 mg/m²) /day) was started (C0 3-6 ng/mL). Six months after KTX prednisolone was set to alternate dose and stopped 3 months later. All 20 protocol biopsies 6 months after KTX showed no acute rejection or borderline findings. Indication biopsies resulted in no acute rejections and two borderline findings. Mean glomerular filtration rate (GFR) 1 year after KTX was 71 ± 25 mL/min/1.73 m². Without cytomegalovirus (CMV)-prophylaxis, only two primary CMV infections were seen despite a donor/recipient-CMV-constellation pos./neg. in 10/20 children. In pediatric KTX, de novo immunosuppression with low-dose CsA, everolimus and steroid withdrawal after 9 months led to promising results according to numbers of acute rejections and infections. Further follow up is needed. Future larger trials will have to confirm our findings.
authors.affiliation: Department of Pediatric Nephrology, Medical School of Hannover, Hannover, Germany. Pape.Lars@mh-hannover.de
authors.forename: L
authors.initials: L
authors.lastname: Pape
authors.forename: G
authors.initials: G
authors.lastname: Offner
authors.forename: M
authors.initials: M
authors.lastname: Kreuzer
authors.forename: K
authors.initials: K
authors.lastname: Froede
authors.forename: J
authors.initials: J
authors.lastname: Drube
authors.forename: N
authors.initials: N
authors.lastname: Kanzelmeyer
authors.forename: J H H
authors.initials: JH
authors.lastname: Ehrich
authors.forename: T
authors.initials: T
authors.lastname: Ahlenstiel
mesh_terms: D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000077552:Basiliximab; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000008:administration & dosage*; D003586:Cytomegalovirus Infections / Q000517:prevention & control; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007223:Infant; D016030:Kidney Transplantation / Q000379:methods* / Q000473:pathology; D008297:Male; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D000068338:Everolimus; D020123:Sirolimus