Randomised, controlled, single blind, multinational and investigator initiated phase II trial, designed to access safety, tolerability and preliminary efficacy.
Kidney transplantation represents the gold standard for patients with ESRD. After transplantation, immunosuppressive drugs are crucial to reducing the risk for organ rejection. Apart from this desired effect, the compromised immunocompetence of the recipient leads to an increased risk for infectious disease. Moreover current immunosuppression regimens are unable to sufficiently control allorecognition of the graft, which leads to chronic rejection. Thus optimal management of immunosuppressive drug dosing requires a delicate balance between inadequate and excessive immunosuppression. At present, there is no diagnostic test or algorithm for optimal guidance of immunosuppressive drugs. Monitoring relies on the quantification of calcineurin inhibitor, mostly tacrolimus, through levels in the peripheral blood, which correlate more closely with the risk of drug-related toxicity than the immunosuppressive efficacy. There is an urgent need for tools to personalise immunosuppression thereby reducing the risk of infectious disease and, at the same time, graft rejection.