title: Pharmacokinetic of cyclosporine microemulsion in pediatric kidney recipients receiving A quadruple immunosuppressive regimen: the value of C2 blood levels.
abstract: BACKGROUND
  The management of cyclosporine therapy in pediatric kidney-transplant recipients is largely based on single center's experience rather than on a univocal pharmacokinetic approach based on therapeutic drug monitoring. A prospective multicenter trial was designed to address the question whether C2 blood level monitoring of cyclosporine microemulsion therapy is feasible in the pediatric setting.
  
  
  METHODS
  Sixty-four pediatric kidney-transplant recipients receiving a triple immunosuppressive regimen based on cyclosporine microemulsion had their cyclosporine dose adjusted to the same protocol-defined C2 targets from the time of the transplant until 2 years posttransplant. The interim analyses after 1 year of enrollment is presented in this study.
  
  
  RESULTS
  One-year patient and graft survival were 100% and 94.8%, respectively. One-year rejection rate was 15%. C2 management of cyclosporine did not affect graft function: 1-year serum creatinine and glomerular filtration rate were 1.3+/-1 mg/mL and 71.2+/-20 mL/min/1.73 m2, respectively. C2 was the best single-point predictor of the area under the concentration curve throughout the entire follow-up, with a mean coefficient of correlation of 0.97+/-0.01.
  
  
  CONCLUSIONS
  C2 management of cyclosporine microemulsion therapy is effective and safe in pediatric kidney-transplant recipients given a combined immunosuppressive treatment.
authors.affiliation: Vascular Surgery and Kidney Transplant Unit, Department of General Surgery and Organ Transplantation, IRCCS, Ospedale Maggiore-Policlinico, Milano, Italy. mariano.ferraresso@unimi.it
authors.forename: Mariano
authors.initials: M
authors.lastname: Ferraresso
authors.forename: Luciana
authors.initials: L
authors.lastname: Ghio
authors.forename: Graziella
authors.initials: G
authors.lastname: Zacchello
authors.forename: Luisa
authors.initials: L
authors.lastname: Murer
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ginevri
authors.forename: Francesco
authors.initials: F
authors.lastname: Perfumo
authors.forename: Gian Franco
authors.initials: GF
authors.lastname: Zanon
authors.forename: Ines
authors.initials: I
authors.lastname: Fontana
authors.forename: Alessandro
authors.initials: A
authors.lastname: Amore
authors.forename: Alberto
authors.initials: A
authors.lastname: Edefonti
authors.forename: Sara
authors.initials: S
authors.lastname: Vigano
authors.forename: Massimo
authors.initials: M
authors.lastname: Cardillo
authors.forename: Mario
authors.initials: M
authors.lastname: Scalamogna
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D015415:Biomarkers / Q000097:blood; D002648:Child; D003175:Complement C2 / Q000032:analysis*; D016572:Cyclosporine / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004655:Emulsions; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007239:Infections / Q000453:epidemiology; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D011183:Postoperative Complications / Q000145:classification; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D015415:Biomarkers; D003175:Complement C2; D004655:Emulsions; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab