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TTV Guide receives CTIS approval

3 August 2022

The TTV Guide-IT clinical trial received approval through the Clinical Trial Information System in July. This marks one of the first multinational academic clinical trial that requested approval directly in the new system and did not migrate from VHP (Voluntary Harmonization Procedure). The aim of TTV Guide is to establish a new and innovative tool to quantify the activity of the immune system in kidney transplant recipients using the Torque Teno virus (TTV). The trial will be carried out in 6 countries: Austria, Czech Republic, France, Germany, Netherlands and Spain.

End stage renal disease (ESRD) causes high socioeconomic burden for citizens and the healthcare system in Europe. Kidney transplantation represents the treatment standard for ESRD. Graft rejection due to inadequate immunosuppression is the leading cause for chronic graft dysfunction and infectious disease due to reduced immune function is a major cause of death. Optimisation of immunosuppressive drugs is a crucial step to minimize the risk of infection and rejection and thereby prolonging patient and graft survival.

TTV Guide-IT is a phase II clinical trial comparing infection and rejection rate between TTV-guided immunosuppression and the clinical routine strategy. 
 
TTV allows for a comprehensive and personalised assessment of the function of the immune system. For the first time this novel and original approach will be tested in an interventional randomised and controlled setting. 
 
The proposed project has the potential to reduce infection and graft rejection by 20% thereby significantly improving graft and patient survival of kidney transplant patients. The improved survival will reduce healthcare costs by ~€ 50 million in the EU per year. The project will serve as a proof-of-concept for TTV-based assessment of the immune system, with potential applications in solid organ transplantation, autoimmune and infectious disease and oncology.