Trial design {8}
PD, infection, ®
INFECTIOUS DISEASES, VIRUS, EVENT, INFECTIOUS DISEASE, INFECTION, KIDNEY, -20
Randomised, controlled, interventional, two-arm, non-inferiority, patient- and assessor-blinded, multinational, investigator-driven, phase II. Trial registry data are summarized in Table Trial registry dataAssoc. Prof. PD. Dr Gregor Bond, PhDNephrology and Dialysis, General Hospital ViennaWähringer Gürtel 18-20, 1090 Vienna, Austriaemail: gregor.bond@meduniwien.ac.atphone/fax: +43 (0)1 40400-43910/-43920Active group: tacrolimus target set according to plasma Torque Teno virus load (target 4.6 to 6.2 logControl: tacrolimus target set according to the local centre standardKey inclusion criteria: recipient of a kidney allograft, adult (≥18 years of age), tacrolimus-based immunosuppression, TTV infectionKey exclusion criteria: high immunological risk, no standard tacrolimus target immunosuppression according to the local centre definitionA composite of one of the following:1. 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 treatmentSARS-CoV-2 infection with or without COVID-19 is excluded.2. 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).3. Graft loss4. Death• Episodes of infection and graft rejection defined by the treating medical personnel• Estimated glomerular filtration rate (eGFR; current CKD-EPI and MDRD abbreviated)• Rejection detected by protocol biopsy at month 12 post-transplantation according to the Banff 2019 meeting report and molecular microscopy• • Health-related quality of life: • Drug adherence assessed according to paper-based assessment, MEMS® Buttons (AARDEX Group, Switzerland), 