NDT Advance Access published online on April 19, 2005
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfh819
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1 Department of Nephrology, Charité, Berlin, Germany
* To whom correspondence should be addressed. Background. Recent developments have proposed the cyclosporin (CsA) concentration at 2 h post-dose (C2) as the best single time-point predictor of the extent of CsA exposure and as the optimal basis for monitoring immunosuppressive therapy in renal transplant patients. The present study sought to validate the cornerstones of the current concept of C2 monitoring. Methods. We assessed the predictive value, dose proportionality and intrapatient variability of C2 levels in 41 de novo renal transplant recipients treated with CsA microemulsion, steroids, mycophenolate sodium and basiliximab. Results. Patients with rejection and patients with CsA nephrotoxicity had lower C2 (P = NS) and absorption (P<0.05 for toxicity), while C0 did not show any significant difference. Receiver operating characteristic analysis did not detect discriminative C2 values as a predictor of rejection or toxicity. In a substantial number of patients (29%) we observed poor and/or slow absorption, with C0 >300 ng/ml and C2 levels <800 ng/ml during the first month and a high rate of complications in these patients (18% rejection, 64% toxicity). Absorption increased over the first month post-transplant. Analysis of dose changes indicated that C2 levels are not dose-proportional. Intrapatient variability of C2 was as high as that of C0. Conclusions. C2 levels do not predict rejection or toxicity. C2 monitoring alone does not detect toxicity in poor and/or slow absorbers, who constitute a significant proportion of patients. Changes in absorption over time, high intrapatient variability and lack of dose proportionality constitute further limitations of the C2 monitoring concept in the early post-transplant phase.
Received April 8, 2004
Accepted March 11, 2005
Original Articles
Limitations of C2 monitoring in renal transplant recipients
2 Institute for Clinical Pharmacology, Charité, Berlin, Germany
3 Department of Urology, Charité, Berlin, Germany
Gunilla Einecke, E-mail: gunilla.einecke{at}ualberta.ca
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