Improved pulse wave velocity and renal function in individualized calcineurin-inhibitor treatment by immunomonitoring: the randomized controlled Calcineurin Inhibitor-Sparing (CIS) Trial

Background A new immune monitoring tool which assesses the expression of nuclear factor of activated T-cells (NFAT)-regulated genes measures the functional effects of cyclosporine A. This is the first prospective randomized controlled study to compare standard pharmacokinetic monitoring by cyclosporine trough levels to NFAT-regulated gene expression (NFAT-RE). Methods Expression of the NFAT-regulated genes was determined by qRT-PCR at cyclosporine trough and peak level. Cardiovascular risk was assessed by change of pulse wave velocity from baseline to month 6. Clinical follow-up was 12 months. Results In total, 55 stable kidney allograft recipients were enrolled. Mean baseline residual NFAT-regulated gene expression was 13.1 ± 9.1 %. Patients in the NFAT-RE group showed a significant decline in pulse wave velocity from baseline to month 6 versus the standard group (-1.7 ± 2.0 vs. 0.4 ± 1.4 m/s, p

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