A multicenter, randomized, open-labeled study to steer immunosuppressive and antiviral therapy by measurement of virus (CMV, ADV, HSV)-specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients (IVIST01-trial): study protocol for a randomized controlled trial

Background After kidney transplantation, immunosuppressivetherapy causes impaired cellular immune defense leading to an increased risk of viral complications. Trough levelmonitoring of immunosuppressantsis insufficient to estimate the individual intensity of immunosuppression. We have already shown that virus-specific T cells (Tvis) correlate with control of virus replication as well as with the intensity of immunosuppression. The multicentre IVIST01-trial should prove that additional steering of immunosuppressiveand antiviral therapy by Tvis levels leads to better graft function by avoidance of over- immunosuppression(for example, viral infections) and drug toxicity (for example, nephrotoxicity).