An international research team coordinated by the Medical University of Vienna has demonstrated the safety of a new biomarker-guided approach to personalising immunosuppressive therapy in kidney transplant recipients. The findings of the TTVguideIT clinical trial, recently presented at the annual congress of the European Renal Association (ERA), suggest that immunosuppressive treatment could, in the future, be tailored more precisely and safely reduced in selected patient groups. The study represents the main outcome of the European Union-funded TTVguideTX project, coordinated by Gregor Bond (Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna), in which the University of Granada team led by David Rodr\u00edguez-Arias Vailhen is a project partner.<\/p>\n\n\n\n
Following kidney transplantation, patients require lifelong immunosuppressive medication to prevent rejection of the transplanted organ. However, excessive immunosuppression increases the risk of infection, whereas insufficient immunosuppression may lead to graft damage or loss. Until now, treatment has been adjusted according to fixed blood drug levels, which provide only a limited indication of each patient’s actual immune status.<\/p>\n\n\n\n
The TTVguideIT study investigated whether the Torque Teno virus (TTV) could serve as a biomarker to guide a more individualised immunosuppressive strategy. TTV is commonly present in healthy individuals and does not cause disease, but its concentration reflects immune activity: low TTV levels may indicate an overactive immune system, whereas high levels may suggest excessive immunosuppression. The researchers therefore adjusted tacrolimus dosing according to TTV measurements rather than relying solely on fixed therapeutic drug targets.<\/p>\n\n\n\n
The phase II randomised controlled trial enrolled 260 stable adult kidney transplant recipients with low immunological and infectious risk across 13 university centres in Austria, Germany, France, the Czech Republic, the Netherlands and Spain. Four months after transplantation, participants were randomly assigned to receive either TTV-guided tacrolimus dosing or standard care. The primary composite endpoint\u2014including infections, graft rejection, graft loss or death\u2014occurred in 35% of patients in the TTV-guided group compared with 38% in the standard-treatment group, demonstrating that the biomarker-guided strategy was non-inferior to conventional management.<\/p>\n\n\n\n
Patients in the TTV-guided group achieved lower tacrolimus blood levels and required lower daily doses without compromising graft safety. Although the study did not demonstrate a statistically significant reduction in infections, the findings indicate that immunosuppressive therapy may be safely reduced in carefully selected low-risk patients. According to project coordinator Gregor Bond, this represents “an important step towards personalised transplant medicine,” highlighting that TTV measurement is already approved for clinical use, is cost-effective, easy to perform and readily standardised.<\/p>\n\n\n\n
TTVguideIT formed part of the Horizon 2020-funded TTVguideTX project, which brought together 20 partners from ten European countries, including transplant centres, virologists, statisticians, ethics experts and industry partners. The study is the first multicentre biomarker trial in organ transplantation to achieve its primary endpoint and the first to guide immunosuppressive therapy using a biomarker. A follow-up multicentre study is already underway in France to evaluate whether the TTV-guided approach also benefits patients beyond the first year after transplantation.<\/p>\n\n\n\n
Study Protocol<\/p>\n\n\n\n
Statisitical Analysis Plan<\/p>\n\n\n\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
An international research team coordinated by the Medical University of Vienna has demonstrated the safety of a new biomarker-guided approach to personalising immunosuppressive therapy in kidney transplant recipients. The findings of the TTVguideIT clinical trial, recently presented at the annual congress of the European Renal Association (ERA), suggest that immunosuppressive treatment could, in the future, be tailored more precisely and safely reduced in selected patient groups. The study represents the main outcome of the European Union-funded TTVguideTX project, coordinated by Gregor Bond (Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna), in which the University of Granada team led by David Rodr\u00edguez-Arias Vailhen is a project partner.<\/p>\n","protected":false},"author":10,"featured_media":1522,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2140","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categorizar"],"acf":[],"yoast_head":"\n