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TX personalisation of immunosuppression by monitoring viral load post kidney transplantation - A randomised controlled phase ii trial
- Call
- Call H2020-SC1-2020-Two-Stage-RTD
- Investigador principal
- Isabel Beneyto
- Role
- Participant
- Year
- 2021
Challenge: 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 one of the leading causes of death following kidney transplantation. Optimization of immunosuppressive drugs is a crucial step to minimize the risk of infection and rejection and thereby prolonging patient and graft survival.
Background: The peripheral blood copy number of the ubiquitous and non-pathogenic torque teno virus (TTV) is associated with the grade of the immunosuppression of its host. Non-interventional studies suggest superiority of TTV copy number guided immunosuppression compared to standard strategies.
Objectives: To demonstrate the safety and preliminary efficacy of TTV-guided dosing of immunosuppressive drugs to reduce infections and rejection.
Method: A phase II trial to compare TTV-guided immunosuppression with the current standard strategy in kidney transplant recipients.
Ambition: The proposed project tests a novel and original approach. TTV allows for analysis of the function of the entire immune system instead of specific compartments. For the first time a holistic assessment of the human immune system will be tested in an interventional randomized and controlled setting.
Impact: The proposed project will impact clinical practice by reducing infection and graft rejection by 20% thereby significantly improving graft and patient survival of kidney transplant patients. The improved dosing will reduce healthcare costs by ~€ 50 million in the EU. The project will serve as a proof-of-concept for TTV bases assessment of the immune system, with potential applications in solid organ transplantation, autoimmune and infectious disease and oncology.