Abstract

A76 Aims: C2 levels management of Ciclosprine-microemulsion (CsA-ME) has been adopted in several countries as an effective method for optimally individualizing therapy for de novo and maintenance renal transplant patients. However, there was no data to evaluate the change of long-term variability of CsA-ME blood concentrations. The aim of this study was to evaluate the change of variability in C2 levels/dose ratio, coefficient of variation of intra- or inter-patients and clinical outcomes in stable renal transplant patients during 2 years. Methods: 8 patients (age 43±12) were enrolled in this study for 2years. The time that had elapsed from after the transplant to the initiation of this study was 3.3±2.1 years. Cyclosporine blood concentrations were measured by FPIA method (AxSYM analyzer), Dose adjustment of CsA-ME was made according to AUC0-4 sparse-sampling that estimated using 2 sampling points (C1, C2) during the maintenance phase (2,000ng.hr/ml) once a month. All patients received CsA-ME -based double or triple therapy (Neoral + Steroids± MMF). Results: Results of inter-patients C2/dose were 371±19 in 2 years (10 times measurements), mean coefficient of variation (CV %) in Inter-patients were 25.8% (13.6%-30.8%). C1/dose were 664±16, mean coefficient of variation (CV%) in Inter-patients were 25.2%(21.4%-33.2%). Results of Intra-patients C2/dose were 371±81, mean coefficient of variation (CV%) in Intra-patients were21.7%. C1/dose were 664±142, mean coefficient of variation (CV%) in Inter-patients were 21.4%. No patients suffered from Chronic rejection or nephrotoxicity during the study. Conclusions: These results suggest that one point C2 (levels) monitoring is optimal CsA-ME administration in stable renal transplant recipients because highly reproducible blood concentrations of Ciclosporine are achieved.

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