Pharmacokinetic of cyclosporine microemulsion in pediatric kidney recipients receiving A quadruple immunosuppressive regimen: the value of C2 blood levels.
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.
Ferraresso
Mariano
M
Vascular Surgery and Kidney Transplant Unit, Department of General Surgery and Organ Transplantation, IRCCS, Ospedale Maggiore-Policlinico, Milano, Italy. mariano.ferraresso@unimi.it
Ghio
Luciana
L
Zacchello
Graziella
G
Murer
Luisa
L
Ginevri
Fabrizio
F
Perfumo
Francesco
F
Zanon
Gian Franco
GF
Fontana
Ines
I
Amore
Alessandro
A
Edefonti
Alberto
A
Vigano
Sara
S
Cardillo
Massimo
M
Scalamogna
Mario
M
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
D000911:Antibodies, Monoclonal; D015415:Biomarkers; D003175:Complement C2; D004655:Emulsions; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab