Primary endpoint
infection, death, infections
INFECTIOUS DISEASES, GRAFT LOSS, SARS-COV-2 INFECTION, DISEASE, EVENT, INFECTIONS, INFECTION, KIDNEY
The primary endpoint is designed to target the most relevant, frequent and significant consequences of too-intense or insufficient immunosuppression—infection and graft rejection—that might be reduced by personalised TTV-guided immunosuppression, along with the two main safety outcomes in kidney transplantation—graft loss and death.The occurrence of a composite of one of the following during the interventional part of the study will be noted (V1 to V7; absolute numbers and percentages):Infectious disease event (diagnosis based on the Infectious Diseases Guidelines 2019 published by the American Society of Transplantation) requiring one of the following:Application of anti-bacterial, -fungal, -viral and -protozoal drugs.Reduction of immunosuppression.Inpatient treatment.SARS-CoV-2 infection with or without COVID-19 is excluded.Allograft rejection detected upon indication biopsy, based on the Banff 2019 Kidney Meeting Report, including borderline rejection suspicious for T-cell-mediated rejection (BL TCMR).Graft lossDeathRoutine calls every 2 weeks will be performed to detect infections treated outside the study centre. For the primary endpoint analysis, all episodes of infection and allograft biopsy will be re-assessed by personnel blinded to the randomisation code.