TRough vs AUC Monitoring of cyclosporine:
A randomized comparison of adverse drug reactions in allogeneic stem cell recipients

In this study the Therapeutic Drug Monitoring of cyclosporine with dried blood spot is investigated in allo SCT recipients. The routine therapeutic drug monitoring of CsA using predose ‘‘trough’’ concentration (C0) is accepted practice. Pharmacokinetic studies in renal transplant patients found that the 12-hour area under the concentration–time curve (AUC[0–12h]) is a very sensitive predictor of acute rejection incidence and graft survival at 1 year post-renal transplant [69] and that it is the best estimate of overall drug exposure, but it is not practical for routine clinical management.
Development of the Dry Blood Spot (DBS) sampling have made AUC[0-12h] monitoring more feasible. Patients can perform the fingerprick at home, no invasive procedure is necessary and monitoring at any desired sampling time can be undertaken conveniently.
Objective: The number and severity of adverse drug reactions (renal function, nausea and tremor) of cyclosporine using AUC targeted Therapeutic Drug Monitoring as compared to C0 targeted TDM.
Study design: Single-blind monocentre intervention study
Study population: Patients planned to undergo an allo SCT for malignant hematological disorders and with a related or unrelated 8/8 HLA matched donor are eligible for randomization.

The number and severity of adverse drug reactions (renal function, nausea and tremor) of cyclosporine using AUC targeted Therapeutic Drug Monitoring as compared to C0 targeted TDM.

CsA monitoring and dose adjustments will be based on trough levels (arm 1) or abbreviated AUC[0-12] (arm 2)