After kidney transplantation (Tx) immunosuppressive therapy causes an impaired cellular immune defense with an increased risk of viral complications. Virus-specific T cells (Tvis) correlate with control of virus replication as well as with the intensity of immunosuppression. Serving as an indicator of overimmunosuppression, monitoring of Tvis may optimize individual timing of antiviral therapy and dosing of immunosuppressants (effect-related drug-monitoring). The ongoing IVIST01-trial proves that steering of immunosuppressive and antiviral therapy by Tvis levels leads to better graft function by avoidance of overimmunosuppression and drug toxicity.

The IVIST01-trial is a prospective, multicenter, randomized study starting 4 wks after Tx and ending 24 months after Tx. 64 pediatric kidney recipients are randomized either to an intervention group with additional Tvis monitoring or to a non-intervention group. In both groups the immunosuppressive drugs (CsA; everolimus) are adjusted within the same target range of trough levels. In the non-intervention group the immunosuppressants are only steered by classical trough level monitoring and the antiviral therapy of CMV-infections is performed according to a standard protocol. In contrast, in the intervention group the dose of immunosuppressants is additionally adjusted according to Tvis levels and antiviral management of CMV-infections is based on the individual number of CMV-Tvis. Levels of Tvis against different virus types (CMV, HSV, ADV) are measured by cytokine flow cytometry. Primary endpoint of the IVIST01-trial is the glomerular filtration rate 2 years after Tx; secondary endpoints are number and severity of viral infections and incidence of side effects of immunosuppressive and antiviral drugs.

Until now 39 pts (61%) have been randomized and 21 pts have already completed the study period. Seven patients became drop-outs because of change of the immunosuppressive regimen.

The IVIST01-trial provides a novel concept of personalization of immunosuppressive and antiviral management after kidney Tx. The study design aims to improve graft function by steering the immunosuppressive and antiviral therapy by Tvis monitoring. Until now study course and recruitment are favorable.

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