Comparison of cyclosporine absorption profiles over a 12-month period in stable pediatric renal transplant recipients

Wigger, M.; Drückler, E.; Muscheites, J.; Stolpe, H.J.; Kundt, G.; Wacke, R.

doi:10.1016/S0041-1345(03)00520-7

« Previous Next »Transplantation Proceedings
Volume 35, Issue 4 , Pages 1300-1303, June 2003

Comparison of cyclosporine absorption profiles over a 12-month period in stable pediatric renal transplant recipients

M. Wigger
- Department for Paediatric Nephrology and Dialysis of the Children’s Hospital, University of Rostock, Germany
- Address reprint requests to Dr Marianne Wigger, University of Rostock, Children’s Hospital, Department for Paediatric Nephrology & Dialysis, Rembrandtstr, 16/17, Rostock 18057, Germany
E. Drückler
- Department for Paediatric Nephrology and Dialysis of the Children’s Hospital, University of Rostock, Germany
J. Muscheites
- Department for Paediatric Nephrology and Dialysis of the Children’s Hospital, University of Rostock, Germany
H.J. Stolpe
- Department for Paediatric Nephrology and Dialysis of the Children’s Hospital, University of Rostock, Germany
G. Kundt
- Department for Paediatric Nephrology and Dialysis of the Children’s Hospital, University of Rostock, Germany
R. Wacke
- Department for Paediatric Nephrology and Dialysis of the Children’s Hospital, University of Rostock, Germany

Abstract

Evidence suggests that the pharmacokinetic (PK) profile of microemulsion- cyclosporine A (m-CsA) during the 4-hour absorption phase represents an accurate tool to estimate drug exposure. In addition, several reports suggest a close correlation between selected single CsA concentrations at 1, 2, or 3 hours post-dose (C₁, C₂, and C₃) and the abbreviated area under the curve (AUC)_0–4 among pediatric renal transplant patients. However, it is still unclear whether these PK correlations remain stable and reliable over 12 months posttransplant. In this study, we obtained 4-hour pharmacokinetic profiles (AUC_0–4) from stable pediatric renal transplant recipients (phase 1) with repeat measurements 12 months later (phase 2). In addition, we evaluated the optimal single sampling point that correlated with the AUC_0–4 during both phases of the study.

Over 1 year there was no significant change in the AUC_0–4 of m-CsA in pediatric renal transplant recipients. The mean dose-normalized AUC_0–4 values changed by less than 2.5%, namely, 557 versus 545 ng × h/mL per unit dose, respectively. The C₁ value was the sampling point that showed the best correlation with AUC_0–4; C₀ displayed the weakest correlation. No changes in cyclosporine dosing or glomerular filtration rate estimates were observed throughout the study period. This study demonstrates the stability of drug measurements during m-CsA therapy.